UNIPETZ 2 in 1 Hand Sanitizer N Cream by Woosin Cosmetics Co., Ltd. Hand Sanitizer Cream

UNIPETZ 2 in 1 Hand Sanitizer N Cream by

Drug Labeling and Warnings

UNIPETZ 2 in 1 Hand Sanitizer N Cream by is a Otc medication manufactured, distributed, or labeled by Woosin Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UNIPETZ 2 IN 1 HAND SANITIZER N CREAM- benzalkonium chloride cream 
Woosin Cosmetics Co., Ltd.

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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Hand Sanitizer Cream

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)

BENZALKONIUM CHLORIDE 0.13%. 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

  • in children less than 2 months of age
  • on open skin wounds

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

74351-2701-1 : 60ml Tube

UNIPETZ 2 IN 1 HAND SANITIZER N CREAM 
benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74351-2701
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ARGININE (UNII: 94ZLA3W45F)  
MACADAMIA OIL (UNII: 515610SU8C)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BETAINE (UNII: 3SCV180C9W)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74351-2701-160 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product06/15/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/15/202007/15/2023
Labeler - Woosin Cosmetics Co., Ltd. (688227829)
Registrant - Woosin Cosmetics Co., Ltd. (688227829)
Establishment
NameAddressID/FEIBusiness Operations
Woosin Cosmetics Co., Ltd.688227829manufacture(74351-2701)

Revised: 5/2021
Document Id: c3988854-aaba-6fc5-e053-2995a90a9030
Set id: a74bb983-f7bf-5299-e053-2995a90a3a8e
Version: 2
Effective Time: 20210530