HAND SANITIZER- alcohol gel 
Colorina Makeup 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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Hand Sanitizer

Drug Facts

Active ingredient(s)

Alcohol 70 v/v

Purpose

Antiseptic

Use(s)

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

Directions

Other information

Inactive ingredients

aqua, glycerin, acrylates / c10-30 alkyl acrylate crosspolymer, aminomethly propanol, peg-40 hydrogenated castor oil, fragrance

Package Labeling

Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77602-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77602-000-6060 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/06/2020
Labeler - Colorina Makeup Inc (942265781)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Pure Essential Cosmetic Co., Ltd.543035759manufacture(77602-000)

Revised: 5/2020
Document Id: a62c79bb-718d-4cd9-e053-2a95a90a53f2
Set id: 1b072522-d4ab-47d8-b8f1-3b2ed7c7c657
Version: 2
Effective Time: 20200521
 
Colorina Makeup Inc