HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Giant Eagle, Apollo Health and Beauty Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic, Hand Sanitizer

Uses

For personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only.

• Flammable.
• Keep away from source of heat or fire.

When using this product

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not inhale.

Do not use

Do not use

• On children less than 2 months of age
• On open skin wounds
• On broken or damaged skin.

Stop use and ask a doctor

Stop use and ask a doctor If irritation or redness develops and lasts.

Keep out of reach of children

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• For occasional and personal use.
• Rub thoroughly into hands for at least 30 seconds. Allow to dry.
• Children under 6 years should be supervised when using this product.

Other information

• Store at a temperature below 110ºF (43ºC).
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water (Aqua), PEG-6, Fragrance, (Parfum), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanate Crosspolymer.

Questions or comments?

1-866-695-3030

Package Label - Principal Display Panel

Package Label - Principal Display Panel

Package Label - Principal Display Panel

Pavkage Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56194-503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56194-503-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2021
2	NDC: 56194-503-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2021
3	NDC: 56194-503-03	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2021
4	NDC: 56194-503-04	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/01/2021

Labeler - Giant Eagle (929989007)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(56194-503)