FOREVER HAND SANITIZER HAND SANITIZER- alcohol gel
Aloe Vera of America, 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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Drug Facts for an OTC drug listing SPL for Forever Hand Sanitizer

Active Ingredients

Active ingredient Purpose
Ethyl Alcohol 62%...Antimicrobial

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice (Stabilized* Aloe Vera Gel), Honey, Isopropyl Alcohol, Fragrance (Parfum), Glycerin, Tetrahydroxypropyl, Ethylenediamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Isopropyl Myristate.

Purpose Section

Uses

hand sanitizer to decrease bacteria on the skin
recommended for repeated use

Warnings

Fore external use only.

Flammable. Keep away from fire or flame.

Indications & Usage

do not use in or near the eyes. If contact occurs, rinse throughly with water.
avoid contact with broken skin.

Stop use and ask a doctor if

rash or irritation develops and lasts.

Keep out of reach of children

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

Dosage & Administration Directions

Directions

wet hands thoroughly with product
briskly rub hands together until dry
children under 6 years of age should be supervised when using this product

Other information

store at 20°C to 25°C (68°F to 77°F) when possible. Do not store above 40°C (104° F).
may discolor certain fabrics

Package Label Principal Display Panel

image of product label Label

FOREVER HAND SANITIZER HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11697-318
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	36.58 mL in 59 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Honey (UNII: Y9H1V576FH)
Isopropyl Alcohol (UNII: ND2M416302)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
Cymbopogon Citratus Leaf (UNII: 06JMS448M5)
Glycerin (UNII: PDC6A3C0OX)
EDETOL (UNII: Q4R969U9FR)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Isopropyl Myristate (UNII: 0RE8K4LNJS)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11697-318-02	59 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	08/16/2010

Labeler - Aloe Vera of America, Inc. (049049463)