HAND SANITIZER- ethyl alcohol solution

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v

Purpose

Antiseptic

Use

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

Warnings

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

DO NOT USE

Do not use

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

When using this product

• do not get into eyes, ears, and mouth.
• if contact occurs, rinse eyes thoroughly with water.

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.

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 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).

Inactive Ingredients

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

Package Label - Principal Display Panel

16.9 Fl. oz. (500 mL) - NDC: 69276-101-14

neobourne
PHARMA

THE
ESSENTIAL

Hand Sanitizer
Gel

KILLS GERMS AND BACTERIA
99.9%

Alcohol antiseptic 70%
Non-sterile topical solution

16.9 Fl. oz. (500 mL)
NDC: 69276-101-69

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69276-101
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69276-101-14	150 mL in 1 TUBE; Type 0: Not a Combination Product	05/20/2020
2	NDC: 69276-101-21	50 in 1 CARTON	05/20/2020
2		3 mL in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 69276-101-45	260 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
4	NDC: 69276-101-69	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
5	NDC: 69276-101-76	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
6	NDC: 69276-101-83	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2020
7	NDC: 69276-101-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2020

Labeler - Neobourne Pharma LP (202909586)

Establishment
Name	Address	ID/FEI	Business Operations
Les Entreprises Stefmar Inc		240496385	manufacture(69276-101)