Label: AIROCARE- sodium hypochlorite liquid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated January 13, 2021
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SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Active Ingredient(s)
- Do not use
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
sodium hypochlorite liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81436-0010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM HYPOCHLORITE (UNII: DY38VHM5OD) (HYPOCHLORITE ION - UNII:T5UM7HB19N) SODIUM HYPOCHLORITE 1.5 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 99.85 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81436-0010-1 20000 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/13/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/13/2021 Labeler - Yukang Co.,Ltd. (694485774) Registrant - Yukang Co.,Ltd (694485774) Establishment Name Address ID/FEI Business Operations Yukang Co.,Ltd. 694485774 manufacture(81436-0010)