CO Bigelow Alcohol Hand Sanitizer

CO Bigelow Alcohol Hand Sanitizer by

Drug Labeling and Warnings

CO Bigelow Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ivresse Internacional, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CO BIGELOW ALCOHOL HAND SANITIZER- alcohol gel 
Ivresse Internacional, 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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CO Bigelow Alcohol Hand Sanitizer

Drug Facts

Active ingredients

Ethyl alcohol 70 % v/v

Purpose

Antiseptic

Uses

  • To decrease bacteria on the skin when water, soap & towel are not available.
  • Recommended for repeated use.

Warnings

For external use only

  • Flammable. Keep away from heat or flame.

When using this product:

  • Keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.
  • Do not use on broken or irritated skin.

Stop use and ask a doctor if

irritation or redness develop and last more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.

Other information

  • Do not store above 105 °F (40°C)
  • May discolor certain fabrics and wood surfaces

Inactive ingredients:

water, carbomer, triethanolamine, glycerin, propylene glycol, aloe barbadensis leaf juice.

Package Labeling:

Bottle

CO BIGELOW ALCOHOL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78740-005
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)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78740-005-0440 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/202012/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/25/202012/01/2022
Labeler - Ivresse Internacional, S.A. de C.V. (814233193)

Revised: 9/2023
Document Id: 053f02f1-a152-5713-e063-6394a90a953f
Set id: 304cf9bd-5fc6-440e-9298-23f198201f7c
Version: 4
Effective Time: 20230913