CO BIGELOW by Ivresse Internacional, S.A. de C.V. CO BIGELOW

CO BIGELOW by

Drug Labeling and Warnings

CO BIGELOW 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 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

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 throughly with water.

Do not use on broken or irritated skin.

Stop use and ask a doctor if

rritation 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

CO BIGELOW 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78740-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78740-001-01	40 mL in 1 TUBE; Type 0: Not a Combination Product	06/18/2020	06/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/18/2020	06/18/2020

Labeler - Ivresse Internacional, S.A. de C.V. (814233193)

Revised: 9/2023

Document Id: 053e76f0-8ca3-645d-e063-6394a90a01d2

34390-5

Set id: 12acb1bc-814f-430c-8db1-4714b7214e0e

Version: 3

Effective Time: 20230913