HAND SANITIZER- isopropyl alcohol gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Alexander Sprekenhus AS, BotanicaLabs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ISOPROPYL ALCOHOL  70%

PURPOSE

ANTISEPTIC

USES

Apply to hands, and rub to help reduce bacteria that potentially can cause disease.

WARNING

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

DO NOT USE

• in 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 eyes thoroughly with water.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

• Place enough product on hands to cover all surtaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

OTHER INFORMATION

• Store between 15-30° C {58-86° F)
• Avoid freezing and excessive heat above 40° C (104° F)

INACTIVE INGREDIENTS

WATER (AQUA), CARBOMER, GLYCERIN, TRIETHANOLAMINE, FRAGRANCE (PARFUM)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80574-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80574-101-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020
2	NDC: 80574-101-12	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/15/2020

Labeler - Alexander Sprekenhus AS (548540280)

Establishment
Name	Address	ID/FEI	Business Operations
BotanicaLabs, Inc.		038497536	manufacture(80574-101)