Hand Sanitizer by First Step Safety Products Corporation / Zhejiang Enchant Cosmetic Co., Ltd. HAND SANITIZER gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by First Step Safety Products Corporation, Zhejiang Enchant Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Alcohol 68% v/v.

Purpose

Antiseptic, Hand Sanitizer

Use

Use for handwashing to decrease bacteria on the skin.

Warnings

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

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product for external use on hands only. In case of contact with eyes, rinse with water.

STOP USE

Stop use and ask a doctor If irritation and redness develops or presists.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Wet hands with product and rub briskly until dry.

OTHER SAFETY INFORMATION

Do not store above 100F.
May discolor some fabrics.
Harmful to wood finishes and plastics.

Inactive ingredients

Water, Acrylates Copolymer, Aminomethyl propanol, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Fragrance

Package Label - Principal Display Panel

236 mL in 1 BOTTLE NDC: 79195-001-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79195-001
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	68 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON (UNII: 24RS0A988O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79195-001-01	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/29/2020

Labeler - First Step Safety Products Corporation (117554463)

Establishment
Name	Address	ID/FEI	Business Operations
First Step Safety Products Corporation		117554463	label(79195-001)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Enchant Cosmetic Co., Ltd.		527284802	manufacture(79195-001)