HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

• to help reduce bacteria on the skin

Warnings

• For external use only.
• Flammable, keep away from fire or flame

When using this product

• avoid contact with eyes.
• if contact occurs, rinse with water.

Stop using and ask a doctor

• if irritation or redness develops and lasts.

Keep out of reach of children.

• In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

• apply a small amount in your palm and rub hands together briskly until dry. Children under 6 should be supervised when using this product.

Other information

do not store above 110°F (43°C)

Questions/comments?

1-866-322-2439

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Actate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Label Copy

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-253-03	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/27/2017

Labeler - DZA Brands LLC (090322194)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(55316-253)