HAND SANITIZER- ethyl alcohol solution

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Platinum System Inc, Les Entreprises Stefmar Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Medicinal Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use(s)

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available

Warning

For external use only. Flammable. Keep away from heat or flame

Do not use

• On children less than 2 months of age
• On open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry
• Supervise children under 6 years of age when using this product to avoid swallowing

Other information

• Store between 15-30°C (59-86°F)
• Avoid freezing and excessive heat above 40°C (104°F)

Non-Medicinal Ingredients

water, glycerin, carbomer, parfume, aloe barbadensis leaf extract, tocopheryl acetate, triethanolamine

Package Label - Principal Display Panel

150 mL NDC: 71316-101-14

ÉLIMINE LES GERMES
99,9%
KILLS GERMS

GelShop

HAND SANITIZER
DÉSINFECTANT
POUR LES MAINS

Alcohol antiseptic 70%
Non-sterile topical solution

Alcool antiseptique 70%
Solution topique non stérile

150 mL (5.1 Fl. Oz.)

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78795-101
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78795-101-45	260 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2020
2	NDC: 78795-101-69	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2020
3	NDC: 78795-101-76	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2020
4	NDC: 78795-101-83	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2020
5	NDC: 78795-101-21	50 in 1 CARTON	06/26/2020
5		3 mL in 1 PACKET; Type 0: Not a Combination Product
6	NDC: 78795-101-14	150 mL in 1 TUBE; Type 0: Not a Combination Product	06/26/2020
7	NDC: 78795-101-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	06/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/26/2020

Labeler - Platinum System Inc (204092162)

Establishment
Name	Address	ID/FEI	Business Operations
Les Entreprises Stefmar Inc		240496385	manufacture(78795-101)