SURFACE HAND SANITIZER- alcohol gel

SURFACE HAND SANITIZER by

Drug Labeling and Warnings

SURFACE HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Welburn Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Alcohol 70% v/v

Purpose

Antiseptic

Uses

Hand Sanitizer 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

• On children less than 2 months of age.
• On open skin wounds.

When using this product

• Keep out of eyes, ears and mouth. In case of contact with eyes rinse thoroughly with water.

Stop use and ask a doctor if

• Stop use and seek 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 of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F).
• Avoid freezing and excessive heat above 40C (104F).

Inactive ingredients

Water, Carbomer, Glycerin, Aloe Barbadensis Leaf Juice, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

Questions?

call 888 387 3887

Company Information

Distributed by:

Welburn Corporation

Hermosa Beach, CA 90254

Made in Guatemala

Product Packaging - 500ml

WITH ALOE VERA

SURFACE

HAND SANITIZER

ANTISEPTIC GEL

MADE WITH 70% ALCOHOL

TRICLOSAN-FREE

FRAGRANCE-FREE

MOISTURIZING

16.9 FL OZ / 500ml

INGREDIENTS AND APPEARANCE

SURFACE HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77622-005
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77622-005-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
2	NDC: 77622-005-02	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
3	NDC: 77622-005-04	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
4	NDC: 77622-005-03	280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
5	NDC: 77622-005-05	458 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
6	NDC: 77622-005-06	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
7	NDC: 77622-005-07	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
8	NDC: 77622-005-08	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020
9	NDC: 77622-005-09	1000000 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/27/2020
10	NDC: 77622-005-10	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020

Labeler - Welburn Corporation (117515830)