HELIOS HAND SANITIZER- alcohol gel

HELIOS Hand Sanitizer by

Drug Labeling and Warnings

HELIOS Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pretty Woman LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only: hands. Flammable. Keep away from fire or flame.

WHEN USING

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin
• do not inhale or ingest

STOP USE

Stop use and ask a doctor if

• irritation or redness develops
• conditions persists more that 72h

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6 years of age, use only under adult supervision
• not recommended for infants

Other information

Other information

• store below 104ºF (40ºC)
• may discolor certain fabrics or surfaces

Inactive ingredients

acrylates copolymer, aminomethyl propanol, fragrance, glycerin, water

Package Label - Principal Display Panel

80 mL NDC: 74140-200-01

INGREDIENTS AND APPEARANCE

HELIOS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74140-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74140-200-01	80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/21/2020

Labeler - Pretty Woman LLC (008134996)

Establishment
Name	Address	ID/FEI	Business Operations
Pretty Woman LLC		008134996	manufacture(74140-200) , pack(74140-200) , label(74140-200)