TOPICAL HAND SANITIZER- ethyl alcohol gel

Topical Hand Sanitizer by

Drug Labeling and Warnings

Topical Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 63%

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.
Do not use on children less than 2 months of age or on open skin wounds.

When using this product

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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 immediately.

Directions

• Place enough product in palm to cover hands and rub together until dry.
• Supervise children under the age of 6 when using this product.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients:

Water (Aqua), Glycerin, Carbomer, Aminomethyl Propanol.

Package/Label Principal Display Panel

FMI – All In!

Topical Gel Hand Sanitizer
NDC: 13564-100-00

Mfg By: FMI, 100 Cascade Dr.
Allentown, PA 18109

2 fl. oz. (59.2 mL)

Label

INGREDIENTS AND APPEARANCE

TOPICAL HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13564-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13564-100-00	59.2 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020
2	NDC: 13564-100-01	236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/03/2020

Labeler - Fragrance Manufacturing, Inc. (793406000)

Registrant - Fragrance Manufacturing, Inc. (793406000)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(13564-100)