WINTER FROST HAND SANITIZER- ethyl alcohol gel

Winter Frost Hand Sanitizer by

Drug Labeling and Warnings

Winter Frost 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 Ingredients

Ethyl Alcohol (70%)

Purpose

Antiseptic

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

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Do not Inhale.

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

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 Centre 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 110 0F (43 0C)
• May discolor certain fabrics or surfaces

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanate Crosspolymer, Fragrance (Parfum), Isopropyl Myristate, Glycerin, Isopropyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Blue 1 (Cl42090)

Principal Display Panel

INGREDIENTS AND APPEARANCE

WINTER FROST HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-727
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)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIRECT BLUE 1 (UNII: 8NN34MAQ6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-727-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	07/08/2021

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(63148-727)