CARE HAND- isopropyl alcohol gel 
PENSEUR KREATIVA GROUP

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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PENSEUR HAND SANITIZER

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. Isopropyl Alcohol (70%, 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. Carbopomer (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)

Isopropyl Alcohol 70% 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

3785 NDC: 81227-101-01

3785 ml label

CARE HAND 
isopropyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81227-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.425 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81227-000-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
2NDC:81227-000-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
3NDC:81227-000-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
4NDC:81227-000-04237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
5NDC:81227-000-05296 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
6NDC:81227-000-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
7NDC:81227-000-07946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
8NDC:81227-000-081892.71 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
9NDC:81227-000-092 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product01/01/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/15/2020
Labeler - PENSEUR KREATIVA GROUP (817469188)
Registrant - PENSEUR KREATIVA GROUP (817469188)
Establishment
NameAddressID/FEIBusiness Operations
PENSEUR KREATIVA GROUP817469188manufacture(81227-000)

Revised: 2/2022
Document Id: d8b099c9-a63c-e3ad-e053-2a95a90ab27e
Set id: b63d0bf6-af2a-24f2-e053-2a95a90a57b4
Version: 9
Effective Time: 20220223
 
PENSEUR KREATIVA GROUP