PRO CLEAN INSTANT HAND SANITIZER- alcohol liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Available from:

Sistemas de Sanitazion y Fragancias Avanzados S.A.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

To help reduce bacteria and germs on the skin that potentially can cuase disease. Recommended for repeated use

Authorization status:

OTC monograph not final

Summary of Product characteristics

PRO CLEAN INSTANT HAND SANITIZER- ALCOHOL LIQUID
SISTEMAS DE SANITAZION Y FRAGANCIAS AVANZADOS S.A.
_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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PRO CLEAN INSTANT HAND SANITIZER
_DRUG FACTS_
_ACTIVE INGREDIENT[S]_
Ethyl Alcohol 70%
_PURPOSE_
Antiseptic
_USE[S]_
To help reduce bacteria and germs on the skin that potentially can
cuase disease. Recommended for
repeated use
_WARNINGS_
FOR EXTERNAL USE ONLY.
FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME
DO NOT USE
in eyes, in case of contact rinse eyes thoroughly with water
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.
_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 20-25C (68-77F)
Avoid freezing and excessive heat above 40C (104F)
_INACTIVE INGREDIENTS_
Water, carbomer, triethanolamine, glycerin.
PACKAGE LABELING:29ML
PACKAGE LABELING:59ML
PACKAGE LABELING:236ML
PACKAGE LABELING:295ML
PACKAGE LABELING:473ML
PACKAGE LABELING:3785ML
PRO CLEAN INSTANT HAND SANITIZER
alcohol liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:8 0 570 -0 0 1
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
0 .7 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)
TR