HDX HAND SANITIZER- ethyl alcohol liquid

HDX Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 70% (v/v)

Purpose

Antiseptic

Use

to help reduce bacteria on the skin.

Warnings

For external use only.

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

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use 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 immediately.

Directions

• Put enough hand sanitizer in your palm to cover hands and rub hands together until dry.
• Children under 6 years should be supervised when using this product.

Other information

• store at a temperature below 110°F (43°C)
• may discolor certain fabrics or surfaces

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl  Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090).

Label copy

INGREDIENTS AND APPEARANCE

HDX HAND SANITIZER 
ethyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-479
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-479-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2016
2	NDC: 63148-479-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/18/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/18/2016

Labeler - Apollo Health and Beauty Care (201901209)

Registrant - Apollo Health and Beauty Care (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care		201901209	manufacture(63148-479)