SOPURE HAND SANITIZER GEL- isopropyl alcohol 70% gel hand sanitizer gel

SoPure Hand Sanitizer Gel by

Drug Labeling and Warnings

SoPure Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by EnviroServe Chemicals & Cleaners Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Isopropyl Alcohol 70% v/v. Purpose : Antiseptic

SPL UNCLASSIFIED SECTION

Purpose

Hand Sanitizer-Antiseptic

Uses

Hand sanitizing to reduce bacteria on the skin

Warnings

• Flamable. Keep away from fire or flame 
• For external use only
• When using this product avoid contact with eyes. In case of eye contact, flush eyes with water 
• Stop use and ask a doctor if irritation or rash appears and lasts
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Do not use

• in 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, 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.

Stop use section

Stop use and ask a doctor if irritation or rash occurs. These may be a sign of a serious condition.

Keep out of reach of children

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

Directions

• Dispense enough product in your palm to cover hands and rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Other information

• Store between 15-30C (59-86F)
• Avoid freesing and excessive heat above 43C (110F)

Inactive ingredients

Glycerin, Polysorbate 20, Amino Methyl Propanol, purified water USP, Vitamin E, Carbomer

Package Label- Principal Display Panel

16.9 FL OZ (500 mL) NDC: 80773-004-01

SoPure hand Sanitizer

INGREDIENTS AND APPEARANCE

SOPURE HAND SANITIZER GEL 
isopropyl alcohol 70% gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80773-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.0133 mL  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.0045 mL  in 1 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.0035 mL  in 1 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.003 mL  in 1 mL
WATER (UNII: 059QF0KO0R)	0.2747 mL  in 1 mL
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)	0.001 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80773-004-01	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	02/16/2024

Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)

Establishment
Name	Address	ID/FEI	Business Operations
EnviroServe Chemicals & Cleaners Ltd		243690711	manufacture(80773-004)