TOPICARE THERAPEUTICS HAND SANITIZER- ethyl alcohol gel

Topicare Therapeutics Hand Sanitizer by

Drug Labeling and Warnings

Topicare Therapeutics Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Topicare Management, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Ethyl Alcohol 73.3%

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

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 and ask a doctor if irritation or rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs.

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

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store between 15-30°C (59-86°F)

Avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Klucel H hydroxypropyl cellulose, Deionized Water, Ceraphyl 31 ester, Glycerin

Package Label - Principal Display Panel

59mL NDC: 70112-300-02

118mL NDC: 70112-300-04

236mL NDC: 70112-300-08

473mL NDC: 70112-300-16

3.79L NDC: 70112-300-01

INGREDIENTS AND APPEARANCE

TOPICARE THERAPEUTICS HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70112-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	73.3 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
MYRISTYL LACTATE (UNII: 1D822OC34X)
LAURYL LACTATE (UNII: G5SU0BFK7O)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
CETYL LACTATE (UNII: A7EVH2RK4O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70112-300-01	3790 mL in 1 JUG; Type 0: Not a Combination Product	09/01/2020
2	NDC: 70112-300-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
3	NDC: 70112-300-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
4	NDC: 70112-300-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020
5	NDC: 70112-300-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/01/2020

Labeler - Topicare Management, LLC (079902303)

Establishment
Name	Address	ID/FEI	Business Operations
Topicare Management, LLC		079902303	manufacture(70112-300)