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, S.A.

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, 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._
----------
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, quaternary ammonium, glicerin. May contain:
carbomer,
hydroxyethylcellulose, triethanolamine.
PACKAGE LABELING:
SCENTIA HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:79 10 3-0 0 3
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
TRO LAMINE (UNII: 9 O3K9 3S3TK)
Laboratorios Quimico-Farmaceuticos Lancasco, S.A.
ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
HYDRO XYETHYL CELLULO SE, UNSPECIFIED (UNII: T4V6 TWG28 D)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:79 10 3-0 0 3-0 1
6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
12/30 /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 rt333E
12/30 /20 20
LABELER -
Laboratorios Quimico-Farmaceuticos Lancasco, S.A. (846092781)
Revise