BULK HAND SANITIZER- alcohol gel
HEAL THE WORLD, 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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Active Ingredient

Ethyl Alcohol 70% v/v.

Purpose

Antimicrobial

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.
For external use only.
When using this product avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry.

Children under 6 years of age should be supervised when using product.

Other information

Store below 110° F (43° C). May discolor certain fabrics or surfaces.

Inactive ingredients

Purified Water (Aqua), Glycerin, Acrylates Copolymer, Tocopherol Acetate, Triethanolamine, Fragrance (Parfum)

Package Label - Principal Display Panel

Label

BULK HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73973-001
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73973-001-01	1040990 mL in 1 CONTAINER; Type 0: Not a Combination Product	06/09/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/09/2020

Labeler - HEAL THE WORLD, LLC (117458258)

Name	Address	ID/FEI	Business Operations
Establishment
American Chemical LLC		117076305	manufacture(73973-001)