ALOE VERA LEAF HAND SANITIZER- alcohol gel
UI Global Brands 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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ALOE VERA LEAF HAND SANITIZER

Drug Facts

Active ingredient

Alcohol Denat. 75%

Purpose

Antimicrobial

Uses

To decrease bacteria on the skin and clean hands. Recommended for repeated use.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Keep out of reach of children. Do not get into eyes.

If contact occurs, rinse thoroughly with water.

Discontinue use

if irritation occurs or redness develops. If irritation persists for more than 72 hours, consult a doctor.

Directions

Apply to hands until thoroughly wet. Rub vigorously until dry.

Inactive Ingredients

Water (Aqua), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Extract, Fragrance (Parfum), Triethanolamine, Tocopheryl Acetate (Vitamin E), Retinyl Palmitate (Vitamin A)

240 mL

240mL

Package Labeling:500ml

500mL

ALOE VERA LEAF HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74856-025
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.75 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A (UNII: 81G40H8B0T)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74856-025-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2020	03/01/2021
2	NDC:74856-025-02	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/25/2020	03/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/25/2020	03/01/2021

Labeler - UI Global Brands LLC (049073416)

Revised: 12/2022

Document Id: f047b07c-3733-6ea6-e053-2995a90aa938

Set id: b2d095d8-5051-0973-e053-2a95a90ad502

Version: 2

Effective Time: 20221220

UI Global Brands LLC