HAND SANITIZER- ethyl alcohol gel 
HOUSE AND BEAUTY CARE MEXICO S.A DE C.V

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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Active Ingredient(s)

Ethyl Alcohol 70% ........................ 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

Demineralized Water, Carbomer, Triethanolamine, Glycerin, PropyleneGlycol, Flue Color 1 FD&C

Package Label - Principal Display Panel

1892 ml NDC: 74345-6669-1

1892 ml

1 gallon label

1 Gallon

500 ml NDC: 74345-6669-4

500 ml

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74345-6669
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TRIPHENYLMETHANE (UNII: 8O4UTW9E17)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74345-6669-11892 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:74345-6669-24000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:74345-6669-4500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - HOUSE AND BEAUTY CARE MEXICO S.A DE C.V (812821623)
Establishment
NameAddressID/FEIBusiness Operations
HOUSE AND BEAUTY CARE MEXICO S.A DE C.V812821623manufacture(74345-6669)

Revised: 5/2020
Document Id: a5788a40-11b3-d000-e053-2995a90a4bde
Set id: a24278fc-9cee-7c80-e053-2a95a90ad2d1
Version: 5
Effective Time: 20200512
 
HOUSE AND BEAUTY CARE MEXICO S.A DE C.V