EZ Gel 12 Aloe by BRENNTAG MID-SOUTH, INC.

EZ Gel 12 Aloe by

Drug Labeling and Warnings

EZ Gel 12 Aloe by is a Otc medication manufactured, distributed, or labeled by BRENNTAG MID-SOUTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EZ GEL 12 ALOE- alcohol liquid 
BRENNTAG MID-SOUTH, 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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Active ingredient[s]

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potenially 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

Stop use and ask doctor

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

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Product Name

EZ GEL 12 ALOE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65353-5262
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)	0.35 L  in 100 L
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ALOE (UNII: V5VD430YW9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65353-5262-1	1040 L in 1 TANK; Type 0: Not a Combination Product	02/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/19/2021	12/31/2023

Labeler - BRENNTAG MID-SOUTH, INC. (122625064)

Registrant - BRENNTAG MID-SOUTH, INC. (122625064)

Establishment
Name	Address	ID/FEI	Business Operations
BRENNTAG MID-SOUTH, INC.		122625064	manufacture(65353-5262) , label(65353-5262)

Revised: 9/2023

Document Id: 05f7269d-46ba-b917-e063-6294a90acf76

34390-5

Set id: bbbad572-81fb-6a49-e053-2995a90aaad2

Version: 3

Effective Time: 20230922