Product Scope
Antibacterial and bacteriostatic lotions are used for antibacterial/ bacteriostatic treatment on intact skin, vagina mucosa and oral mucosa, but excluding those applied on specific body parts such as feet, eyes, nails, axilla, scalp, hair, nasal mucosa, and anorectal area, etc. The most typical antibacterial and bacteriostatic lotions used in our daily life are mouthwash, hand sanitizer and feminine wash with an anti-microbial claim.Raw Materials and Banned Substances
All raw materials used shall conform to the quality criteria specified in the Chinese Pharmacopoeia in force, as well as other quality specifications for food grade, medicine grade and cosmetic-grade, etc. The productive water shall satisfy the requirements in the “Hygienic Practice for Producers of Disinfection Products (2009)”. Pharmaceutical active ingredients listed in the Chinese Pharmacopoeia，animal/human-derived and biologically obtained materials that used for disease prevention, treatment and diagnosis, and banned ingredients listed in the “Safety and Technical Standards for Cosmetics”(excluding iodine), as well as other ingredients banned by the health department are prohibited from the formula of antibacterial/ bacteriostatic lotion.Technical Requirements
Antibacterial/bacteriostatic lotion shall comply with a series of technical indicators through physicochemical property, efficacy and toxicological aspects. Its PH value shall be within the range of the value labeled and active ingredients used and harmful substances shall comply with the following limits:| Active Ingredient(g/L) | Skin-use | mucosa |
| Chlorhexidine digluconate/ acetate | ≤45.0 | ≤5.0 |
| Triclosan | ≤20.0 | ≤3.5 |
| Benzalkonium Bromide/ Chloride | ≤5.0 | ≤2.0 |
| Substance(mg/kg) | Skin-use |
| Lead | ≤10 |
| Arsenic | ≤2 |
| Mercury | ≤1 |
| Label Claim | Irritation Test |
| Skin | Multiple skin irritation |
| Rinse-off | 2-hour acute skin irritation only |
| Vagina mucosa | Vagina mucosa irritation |
| mucosa | Eye irritation |
Referenced Testing Methods
The above indicators shall be tested by the method specified in the following technical regulations or standards:| Test | Referenced regulation and standard |
| PH value | Technical specification for disinfection (2002 version) |
| Content of active substance | Technical specification for disinfection (2002 version) or relevant national standard |
| Lead, arsenic and mercury content | Safety and Technical Standards for Cosmetics |
| Stability | Technical specification for disinfection (2002 version) |
| Antibacterial efficacy | Technical specification for disinfection (2002 version) and GB 15979 |
| Bacteriostatic efficacy | Technical specification for disinfection (2002 version) and GB 15979 |
| Microbial contaminant | GB 15979 |
| Toxicological test | Technical specification for disinfection (2002 version) |
- WS/T 684-2020 Analytical method and evaluation requirements for antibacterial drugs in disinfectant and antibacterial and bacteriostatic agents
- WS/T 685-2020 Analytical method and evaluation requirements for antifungal drugs in disinfectant and antibacterial and bacteriostatic agents
- WS/T 686-2020 Analytical method and evaluation requirements for antiviral drugs in disinfectant and antibacterial and bacteriostatic agents.
Labels and Instruction
These body-use antimicrobial products shall follow the basic requirements in the national standard, “GB 38598 2020-General Requirements for Label and Instruction Book of Disinfection Products”, which was also enacted on December 1, 2021. Items of information to be compulsorily displayed on minimum sales packaging, transport packaging and instruction, as well as prohibited function claims and phrases are summarized as follows:| Minimum sales packaging | Transport packaging | Use instruction | |
| Product name | √ | √ | √ |
| Net content | √ | ||
| Name, address and contact information of the manufacturer | √ | √ | √ |
| Hygienic license number of the manufacturer (homemade product) or country/region of origin (imported products) | √ | √ | √ |
| Batch number and expiration date (or production data and validity period) | √ | √ | |
| Storage conditions | √ | ||
| Packing condition | √ | ||
| Precaution for storage and transport | √ | ||
| Name and content of active ingredient used and use scope (For products used on vaginal mucosa, the phase” shall not be used for STD prevention” shall be included) | √ | √ | |
| Application method Use precaution Number of product executive standard product specification for tablet formulation target microbial organism | √ | ||
| Function claims and phrases prohibited from being displayed on product instruction | |||
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- Antibacterial/bacteriostatic lotion shall not be used for disease treatment or symptom improvement;
- This lotion shall not be swallowed. Keep out of children's reach
- Avoid using together with antagonists;
- Do not use if allergy;
- Keep Away from light and moisture. Sealed in a cool and dry place.
