SANSATIONAL SANITIZING WIPES- alcohol wipes cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302), ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

GOKSU KAGIT SANAYI VE TICARET LIMITED SIRKETI

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antimicrobial, Alcohol Wipes Alcohol Wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SANSATIONAL SANITIZING WIPES- ALCOHOL WIPES CLOTH
GOKSU KAGIT SANAYI VE TICARET LIMITED SIRKETI
_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._
----------
ACTIVE INGREDIENT(S)
Ethyl Alcohol 63% v/v. Purpose: Antimicrobial
Isopropyl Alcohol 12% v/v. Purpose: Antimicrobial
PURPOS E
Antimicrobial, Alcohol Wipes
US E
Alcohol Wipes to help reduce bacteria that potentially can cause
disease. For use when soap and water
are not available.
WARNINGS
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.
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 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.
DIRECTIONS
Use 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 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS
glycerin, purified water USP
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
100 U NDC: 79509-500-01
SANSATIONAL SANITIZING WIPES
alcohol wipes cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:79 50 9 -50 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2) (ISOPROPYL ALCOHOL -
UNII:ND2M416 30 2)
ISOPROPYL ALCOHOL 12 U in 10 0 U
ALCO HO L (UNII: 3K9 9 58 V