Label: ANJIESHU INSTANT HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 52728-017-01 - Packager: Zhejiang Enchant Cosmetic Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 25, 2020
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- Official Label (Printer Friendly)
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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:
- Isopropyl Alcohol (75%, 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)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
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
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANJIESHU INSTANT HAND SANITIZER
anjieshu instant hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52728-017 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 750 mL in 1000 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 4 mL in 1000 mL AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 3 mL in 1000 mL WATER (UNII: 059QF0KO0R) 242 mL in 1000 mL HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.1 mL in 1000 mL ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.9 mL in 1000 mL Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52728-017-01 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/25/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/25/2020 Labeler - Zhejiang Enchant Cosmetic Co., Ltd. (527284802) Establishment Name Address ID/FEI Business Operations Zhejiang Enchant Cosmetic Co., Ltd. 527284802 manufacture(52728-017)
