ANTIBACTERIAL WET WIPES- benzethonium chloride cloth 
YOYO LIP GLOSS, INC

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.

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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:

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

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 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.

Directions

Other information

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

ANTIBACTERIAL WET WIPES000 mL NDC: 00000-000-00

ANTIBACTERIAL WET WIPES 
benzethonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70611-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HONEY (UNII: Y9H1V576FH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70611-005-0510 in 1 POUCH03/30/2020
11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:70611-005-0680 in 1 POUCH03/30/2020
21 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3NDC:70611-005-07100 in 1 POUCH03/30/2020
31 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4NDC:70611-005-08160 in 1 POUCH03/30/2020
41 mL in 1 APPLICATOR; Type 0: Not a Combination Product
5NDC:70611-005-0916 in 1 POUCH03/30/2020
51 mL in 1 APPLICATOR; Type 0: Not a Combination Product
6NDC:70611-005-1072 in 1 POUCH03/30/2020
61 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - YOYO LIP GLOSS, INC (828881792)
Establishment
NameAddressID/FEIBusiness Operations
ZHEJIANG YOUQUAN CARE PRODUCTS TECHNOLOGY CO., LTD421318425manufacture(70611-005)

Revised: 5/2020
Document Id: a578bf51-41d2-2c5b-e053-2a95a90a55ac
Set id: a578ad4d-3880-055d-e053-2995a90a985a
Version: 1
Effective Time: 20200512
 
YOYO LIP GLOSS, INC