HIGHMARK- alcohol liquid

HiGHMARK by

Drug Labeling and Warnings

HiGHMARK 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%

PURPOSE

Antiseptic

Uses

For personal hand hygine 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.

Do not use

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

When using this product avoid

• Contact with eyes. If contact occurs, rinse eyes throughly with water.
• Do not inhale.

Stop use and ask a doctor

If irritation or redness develop and lasts.

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.

Inactive Ingredients

Water (Aqua), PEG-6, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Fragrance (Parfum), Glycerin, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).

Questions

1-866-795-8481

Principal Display Panel 8 FL OZ

Principal Display Panel 32 FL OZ

INGREDIENTS AND APPEARANCE

HIGHMARK 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63148-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63148-402-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2023
2	NDC: 63148-402-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/01/2023

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(63148-402)