Hand Sanitizer Antiseptic Gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HART Health, WaterJel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- antiseptic gel gel 
HART Health

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Hand Sanitizer Antiseptic Gel

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

HAND SANITIZER 
antiseptic gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50332-5394
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 VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)
WATER (UNII: 059QF0KO0R)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50332-5394-1	10 in 1 BOX, UNIT-DOSE	01/08/2021
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 50332-5394-2	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	12/31/2023

Labeler - HART Health (069560969)

Registrant - HART Health (069560969)

Establishment
Name	Address	ID/FEI	Business Operations
WaterJel Technologies		155522589	manufacture(50332-5394)

Revised: 1/2024

Document Id: 308b5263-070b-4da2-abbc-efe0358f73a8

34390-5

Set id: 2c7110cd-e82d-442a-8738-f8d9c1ea4521

Version: 3

Effective Time: 20240127