75% ALCOHOL HAND SANITIZER- alcohol gel
Pinnacle 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.

----------

75% alcohol hand sanitizer

Alcohol 75% v/v. Purpose: Antiseptic

Antiseptic, Hand Sanitizer

For hand sannitizing to reduce bacteria on the skin.

Flammable. Keep away from fire or flame. For external use only.

Keep away from eyes.

Keep our of reach of children.

Do not inhale or ingest.

Stop use and ask doctor if irritation or redness develops.

Squeeze small amount in your palm and briskly rub hands together and allow to air dry.

For children under 6, use with adult supervision.

Not recommended for infants.

Store below 105F (43C). May discolor certain fabrics or surfaces.

Water, Acrylic Polymer, Triethanolamine, Glycerine.

Package Label - Principal Display Panel

237 mL NDC: 74621-001-04

PDP

75% ALCOHOL HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75690-001(NDC:74621-001)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75690-001-01	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/21/2020

Labeler - Pinnacle Brands LLC (117150686)

Registrant - Aogrand International Trade Corporation (421353092)

Name	Address	ID/FEI	Business Operations
Establishment
Aogrand International Trade Corporation		421353092	manufacture(75690-001) , relabel(75690-001)