ANTIBACTERIAL HAND SANITIZER- alcohol gel

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Calego International Inc.

Mode d'administration:

TOPICAL

Type d'ordonnance:

OTC DRUG

indications thérapeutiques:

For handwashing to decrease bacteria on the skin.

Statut de autorisation:

OTC monograph not final

Résumé des caractéristiques du produit

ANTIBACTERIAL HAND SANITIZER- ALCOHOL GEL
CALEGO INTERNATIONAL INC.
_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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ANTIBACTERIAL HAND SANITIZER
_DRUG FACTS_
_ACTIVE INGREDIENT_
Alcohol 75% v/v
_PURPOSE_
Antiseptic
_USE_
For handwashing to decrease bacteria on the skin.
_WARNINGS_
FOR EXTERNAL USE ONLY. FLAMMBLE.
KEEP AWAY FROM HEAT OR FLAME.
DO NOT USE
on children less than 24 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_
Put enough gel in your palm to cover hands and rub hands together
rapidly until dry.
Children under 6 years of age should be supervised when using this
product.
_OTHER INFORMATION_
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 35C(95F)
_INACTIVE INGREDIENTS_
Aqua, Carbomer, Triethanolamine
PACKAGE LABELING:
ANTIBACTERIAL HAND SANITIZER
alcohol gel
Calego International Inc.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7248 7-0 0 9
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 .75 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)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7248 7-0 0 9 -0 0
30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CIT