SUAVE 75% V/V ALCOHOL WIPES- alcohol solution

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
UNILEVER ASIA PRIVATE LIMITED
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
ANTISEPTIC Hand alcohol wipe to help reduce bacteria on the skin. For use when soap and water are not available.
Authorization status:
OTC monograph not final
Authorization number:
50069-113-11

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SUAVE 75% V/V ALCOHOL WIPES- alcohol solution

UNILEVER ASIA PRIVATE LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Suave 75% v/v ALCOHOL WIPES

ACTIVE INGREDIENT

Ethyl alcohol (75% v/v)

PURPOSE

ANTISEPTIC

USE

Hand alcohol wipe to help reduce bacteria on the skin. For use when soap and water are not available.

WARNINGS

For External Use only.

Flammable. Keep away from fire or flame. Do not store in car.

Do not use:

In children less than 12 months of age.

On open skin wounds.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with

water

Stop use and ask doctor if irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

away.

DIRECTIONS

Wipe hands thoroughly with product and allow to dry

Children under 6 should be supervised when using this product.

OTHER INFORMATION

Dispose used wipes in waste basket

DO NOT FLUSH.

Avoid excessive heat. Store below 105°F (40°C).

May discolor fabrics or surfaces

INACTIVE INGREDIENTS

Denatonium Benzoate, Tert-Butyl Alcohol, Water (Aqua).

SUAVE 75% V/V ALCOHOL WIPES

alcohol solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 0 6 9 -113

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

7.5 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)

TERT-BUTYL ALCO HO L (UNII: MD8 3SFE9 59 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 0 6 9 -113-11 130 in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

12/18 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

12/18 /20 20

Labeler -

UNILEVER ASIA PRIVAT E LIMIT ED (894632699)

UNILEVER ASIA PRIVATE LIMITED

Revised: 2/2021

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