BainD Ete Alcohol Gel by Eurocorp Caribbean LLC / Distribuidora cuscatlan

Drug Details [pdf]

BAIND ETE ALCOHOL GEL- alcohol gel
Eurocorp Caribbean LLC

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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AQUA / WATER

ACRYLATES /C 10-30

CROSSPOLYMER

CARBOMER

AMINOMETHYL PROPANOL

ETHYL ALCOHOL 70 %

FOR EXTERNAL USE ONLY. FLAMMABLE PRODUCT

KEEP AT A TEMPERATURE NOT HIGHER THAN 105 o F.

MAY DISCOLOR SOME FABRICS, HARMFUL TO WOOD FINISHES.

WHEN USING THIS PRODUCT KEEP OUT OF EYES.

IN CASE OF CONTACT, FLUSH THOROUGHLY WIT WATER.

DO NOT INHALE OR INGEST.

STOP USING AND ASK A DOCTOR : IF IRRITATION AND REDNESS DEVELOP AND PERSISTS FOR MORE THEN 24 HOURS.

APPLY A SMALL AMOUNT IN YOUR HANDS AND RUB UNTIL IT DRIES, FOR CHILDREN UNDER 6 USE ONLY UNDER ADULT SUPERVISION.

KEEP OUT OF REACH OF CHILDREN: IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASES.

apply a small amount in your hands and rub until it dries, for children under 6. use only under adult supervision.

To decrease bateria on the skin that could cause diseases.

PACKAGE LABEL FRONT AND BACK

LABEL FRONT AND BACK

BAIND ETE ALCOHOL GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75818-400
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 75818-400-37	3780 mL in 1 JUG; Type 0: Not a Combination Product	09/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/24/2020	12/31/2021

Labeler - Eurocorp Caribbean LLC (087768954)

Name	Address	ID/FEI	Business Operations
Establishment
Distribuidora cuscatlan		851247924	manufacture(75818-400)

Revised: 1/2022

Document Id: d6d989a1-7f09-0fc8-e053-2995a90a180d

Set id: b016a56d-97a2-632d-e053-2995a90a57dc

Version: 2

Effective Time: 20220130