ISOPROPYL RUBBING ALCOHOL 70%- alcohol liquid

ISOPROPYL RUBBING ALCOHOL 70% by

Drug Labeling and Warnings

ISOPROPYL RUBBING ALCOHOL 70% by is a Otc medication manufactured, distributed, or labeled by Artesanales P.R. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using grade ingredients:

Isopropyl Alcohol (USP or Food Chemical Codex) (99% (v/v) in an aqueous solution

water

the firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

ACTIVE INGREDIENT

Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

PURPOSE

Antiseptic, Hand Sanitizer

INDICATIONS & USAGE

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

DO NOT USE

in children less than 2 onths of age

on open skin wounds

WARNINGS

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

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, 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.

STOP USE

Stop use and ask a doctor if irrittion or rash occurs. These may be signs 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 right away.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

store between 15-30C (59-86F)

avoid freezing and excessive heat above 40C (104F)

INACTIVE INGREDIENT

water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ISOPROPYL RUBBING ALCOHOL 70% 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78824-625
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 99 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78824-625-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2020
2	NDC: 78824-625-02	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/03/2020

Labeler - Artesanales P.R. LLC (117238442)

Registrant - Artesanales P.R. LLC (117238442)

Establishment
Name	Address	ID/FEI	Business Operations
Artesanales P.R. LLC		117238442	manufacture(78824-625)