NO-WASH ANTIBACTERIAL- ethanol gel
MAJESTIC GROUP LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NO-WASH ANTIBACTERIAL GEL

Active Ingredient

Ethyl Alcohol

Purpose

Antimicrobial

Uses

Hand-Sanitizer helps to reduce the amount of disease causing bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only.

Do not use this hand sanitizer on or near the eyes.In case of accidental contact, flush eyes thoroughtly with water.
Do not use on broken skin: Do not inhale or ingest.
In case of skin irritation please stop use and talk to doctor.

Directions

Place enough product in your palm to thoroughly cover your hands.
Rub hands togerher thoroughly until dry.
For children under 6 years old use only under adult supevision :Not recommended for use on infants.

Keep out of reach of children

If accidentally swallowed, contact the Poison Control Center or get medical help immediately.

Other Information

Do not store above 110°F (43°C)
May discolor certain fabrics or surfaces

Inactive Ingredient

Water(Aqua),Carbomer,Glycerin,Triethanolamine

Product Label

image description

NO-WASH ANTIBACTERIAL
ethanol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77331-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77331-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
2	NDC:77331-001-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
3	NDC:77331-001-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
4	NDC:77331-001-04	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
5	NDC:77331-001-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
6	NDC:77331-001-06	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
7	NDC:77331-001-07	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
8	NDC:77331-001-08	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
9	NDC:77331-001-09	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
10	NDC:77331-001-10	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
11	NDC:77331-001-11	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
12	NDC:77331-001-12	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
13	NDC:77331-001-13	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020
14	NDC:77331-001-14	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/06/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	05/06/2020

Labeler - MAJESTIC GROUP LLC (080252816)