GNC INSTANT HAND SANITIZER- alcohol gel

GNC Instant Hand Sanitizer by

Drug Labeling and Warnings

GNC Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by GNC Holdings LLC, Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

• hand sanitizer to help reduce bacteria on hands and skin
• recommended for repeated use

Warnings

For external use only

Flammable, keep away from fire or flames

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation and redness develop and persists

Keep out of reach of children

If ingested get medical help or contact a Poison Control Center right away

Directions

• wet hands thoroughly with product
• allow to dry without wiping
• children under 6 should be supervised while using this product

Inactive ingredients

Purified Water, Carbomer, Aloe Vera, Triethanolamine, Fragrance, D&C Green #5, D&C Yellow #10

Principal Display Panel - 118 mL Bottle Label

GNC
LIVE WELL

hand
sanitizer

Ethyl Alcohol 66.5%

FRESH SCENT

NDC: 43655-1111-0

4.0 FL. OZ. (118 mL)

Principal Display Panel - 237 mL Bottle Label

GNC
LIVE WELL

hand
sanitizer

Ethyl Alcohol 66.5%

FRESH SCENT

NDC: 43655-1111-1

8.0 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

GNC INSTANT HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43655-1111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	66.5 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43655-1111-0	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2021
2	NDC: 43655-1111-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/01/2021

Labeler - GNC Holdings LLC (117772252)

Registrant - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc.		874965262	MANUFACTURE(43655-1111)