HAND SANITIZER- antiseptic gel gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HART Health, Safetec of America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl alcohol 62%

Purpose

Antiseptic handwash

Uses

For hanwashing to decrease bacteria on skin. Recommended for repeated use.

Warnings

For external use only

Flammable, keep away from heat and flame

When using this product

• do not use in the eyes
• in case of contact, rinse eyes throughly with water

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6 years of age; use only with adult supervision

Inactive ingrediends

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, fragrance, PEG-60 almond glycerides, propylene glycol, purified water, triisopropanolamine

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
antiseptic gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-0040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-0040-1	10 in 1 BOX, UNIT-DOSE	01/08/2021
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-0040-2	25 in 1 BOX, UNIT-DOSE	01/08/2021
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	01/08/2021

Labeler - HART Health (069560969)

Registrant - HART Health (069560969)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	manufacture(50332-0040)