SCENTIA HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ethanol 70%, Antibacterial 

Available from:

Laboratorios Quimico Farmaceuticos Lancasco SA

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for hand sanitizer to decrease bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

SCENTIA HAND SANITIZER- ALCOHOL GEL
LABORATORIOS QUIMICO FARMACEUTICOS LANCASCO SA
_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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SCENTIA HAND SANITIZER
DRUG FACTS
ACTIVE INGREDIENTS
Ethanol 70%
PURPOS E
Antibacterial
US E
for hand sanitizer to decrease bacteria on the skin.
WARNINGS
FOR EXTERNAL USE ONLY
FLAMMABLE
WHEN USING THIS PRODUCT
Avoid contact with the eyes and mouth.
STOP USE AND ASK A DOCTOR IF
Irritation and redness appear.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately..
DIRECTIONS :
Apply a sufficient amount of product on your hands and rub until
completely dry. Repeat if necessary.
INACTIVE INGREDIENTS:
Isopropyl alcohol, Aqua, quanternary ammonium, glicerine. May contain:
carbomer,
hydoxyethylcellulose, triethanolamine.
PACKAGE LABELING:300 ML
PACKAGE LABELING:1.0L
PACKAGE LABELING:5L
SCENTIA HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:79 10 3-0 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
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE MARKETING END DATE
1
NDC:79 10 3-0 0 1-0 3 30 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio
n Pro duct
0 6 /30 /20 20
2
NDC:79 10 3-0 0 1-0 4 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co
mbinatio n Pro duct
0 6 /30 /20 20
Laboratorios Quimico Farmaceuticos Lancasco SA
3
NDC:79 10 3-0 0 1-0 5 50 0 0 mL in 1 BOTTLE; Type 0 : No t a Co
mbinatio n Pro duct
0 6 /30 /20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING ST