ZAPPP INSTANT HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

LUSINE INDUSTRIA E COMERCIO DE COSMETICOS EIRELI

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic Hand sanitizer to help reduce bacteria that potentially can cause disease.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ZAPPP INSTANT HAND SANITIZER- ALCOHOL GEL
LUSINE INDUSTRIA E COMERCIO DE COSMETICOS EIRELI
_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
Alcohol 70% v/v.
PURPOS E
Antiseptic
US E
Hand sanitizer to help reduce bacteria that potentially can cause
disease.
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 DOCTOR IF irritation and redness develop or if
condition persists more than 72 hours.
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 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS
Carbomer, Water, Glycerin, Aminomethylpropanol, Denatonium benzoate
PRODUCT LABEL
ZAPPP INSTANT HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:78 46 7-0 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
70 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED)
(UNII: 4Q9 3RCW27E)
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)
DENATO NIUM BENZO ATE (UNII: 4YK5Z54AT2)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:78 46 7-0 0 1-
0 1
50 0 mL in 1 BOTTLE,