Analysis of Key Points for Label Compliance of Skin Antibacterial Preparations

In the increasingly competitive disinfectant market, skin antibacterial preparations (such as antibacterial hand sanitizers and skin antibacterial sprays), as high-frequency consumer goods, are a key focus for companies. However, in practice, many companies often underestimate the potential risks associated with labeling. This article deeply analyzes the core compliance requirements for skin antibacterial preparation labeling to help disinfectant companies achieve efficient compliance.

Regulatory Positioning of Skin Antibacterial Preparations

Provincial disinfection product registration is subject to classification management according to the purpose of the disinfection product and the risk level of the user. Skin antibacterial preparations are clearly classified as "second-category disinfection products."

Different packaging labels should be marked with the following content in disinfection products

Detailed labeling requirements for skin antibacterial preparations

Product name labeling requirements

❑ Must be clearly marked on the smallest display surface or visible surface of the packaging to ensure legibility;

❑ Product names must follow the order of "trademark name/brand name + common name + attribute name," with the brand name formatted as "XX Brand." Trademarks must not contain exaggerated functions or mislead consumers;

❑ The same disinfectant product's label or instructions may only carry one product name;

❑ Product names must not contain false, exaggerated, or absolute terms, foreign letters, Chinese pinyin, or symbols (except for model numbers). If the product is a registered trademark or if the use of foreign letters or symbols is necessary, these must be stated in Chinese on the label or instructions, or in the product name itself.。

Active ingredient and content labeling requirements

❑ The visible surface of the smallest packaging must be labeled with the name and content of the main active ingredient, the main bactericidal factor and its strength, or the name and dosage of the main ingredient.

❑ If the main active ingredient is a chemical ingredient, the standardized chemical name and content must be labeled.

❑ If the main active ingredient is a botanical ingredient, the Chinese name of the plant and the dosage per unit volume must be labeled.

❑ If the main active ingredient is a plant extract, the Chinese name of the plant and the indication "extract" must be labeled.

❑ If the main active ingredient is a combination of a chemical and a plant ingredient, the standardized chemical name and content, the Chinese name of the plant, and the dosage per unit volume must be labeled.

Health permit labeling requirements

❑Domestic products must be labeled with the manufacturer's valid health permit number.

Net content labeling requirements

❑ The net content must accurately reflect the actual content, and the tolerance must comply with the "Measurements for the Supervision and Administration of Measurement of Pre-packaged Commodities." If the same minimum sales package contains multiple units of the same pre-packaged product, the net content of each unit and the total number of units must be indicated.

❑ The net content labeling must include "Net Content" (in Chinese), a number, and the legal unit of measurement (or Chinese counting unit).

Instructions for use labeling requirements

❑ Instructions for use must be clear and specific, and can be presented in text or diagrams. If there are two or more methods, the specific requirements for each method must be listed separately.

❑ Instructions for use of antimicrobial preparations, antibacterial preparations, and contact lens care products should include: preparation method (except for products using stock solutions), concentration (expressed as active ingredient content, excluding botanical ingredients), duration of action (not required if the antibacterial ring test is used as the testing method), and method of use.

Precaution labeling requirements

❑ Products that may endanger health, personal safety, or property during use must be labeled with a warning symbol and Chinese warning instructions in a prominent location on a visible surface.

❑ If a product presents foreseeable hazards from improper use or storage, or foreseeable adverse effects, the corresponding warning information must be labeled. If there are adverse effects, additional precautionary information must be provided.

❑ Product storage conditions must be labeled. If storage or transportation conditions have special safety requirements, these must be clearly indicated on the label and instructions.

Production date and expiration date labeling requirements

❑ The label should be clearly visible on the smallest packaging surface.

❑ The production date and expiration date should be marked with the following: year/month/day:

Requirements for labeling the manufacturer's name/address/contact information

❑ The name, registered address, and actual production address of the manufacturer of domestically produced products must be consistent with the information on the manufacturer's health license.

❑ For disinfectant products manufactured on a consignment basis, the name, address, and contact information of the responsible party (the consignor) and the name and address of the actual manufacturer (the consignee) must be labeled simultaneously.

❑ For products manufactured by a non-independent legal entity branch (subsidiary) of the same group, or a non-independent legal entity branch/production workshop of the same manufacturer, the name and address of the responsible party and the actual manufacturer must be labeled separately.

❑ The manufacturer's contact information, including the contact number, must be labeled.

"Prohibited List" for skin antibacterial preparation labels

The following should not be included on labels or instructions for antibacterial (antimicrobial) preparations:

❑ Anti-inflammatory, treatment of disease, alleviation or relief of disease symptoms, description or explanation of disease symptoms, prevention of sexually transmitted diseases;

❑ Suitable for use on damaged skin, damaged mucous membranes, wounds, etc.;

❑ Highly effective, disinfecting, sterilizing, antiseptic, spermicidal, and contraceptive;

❑ For use on the feet, eyes, nails, axillae, scalp, hair, nasal mucosa, and anorectal areas;

❑ A course of treatment of x days, or as directed by a physician; prevents recurrence; promotes wound healing; used as an adjunct to medication.

Throughout the compliance filing process for disinfectant products, labeling is the ultimate expression of compliance, directly linking regulation and usage scenarios. Therefore, addressing labeling compliance is crucial for avoiding major risks like policy penalties and market recalls, ensuring smooth product distribution.

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