VIOLA ROUGE ANTISEPTIC HAND RUB 75 PERCENT- alcohol solution

VIOLA ROUGE ANTISEPTIC HAND RUB by

Drug Labeling and Warnings

VIOLA ROUGE ANTISEPTIC HAND RUB by is a Otc medication manufactured, distributed, or labeled by DELICATE COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ISOPROPYL ALCOHOL 75% V/V

PURPOSE

ANTISEPTIC

USES

HEALTH CARE PERSONNEL HAND RUB TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN IF 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 EYES THOROUGHLY WITH WATER.

STOP USE AND A DOCTOR IF IRRITATION 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.

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 15-30°C (59-86°F)
• AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)

INACTIVE INGREDIENTS

PURIFIED WATER USP, GLYCERIN, HYDROGEN PEROXIDE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VIOLA ROUGE ANTISEPTIC HAND RUB  75 PERCENT
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54594-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54594-201-11	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/30/2020

Labeler - DELICATE COSMETICS INC (137997602)

Establishment
Name	Address	ID/FEI	Business Operations
DELICATE COSMETICS INC		137997602	manufacture(54594-201)