ANTIBACTERIAL HAND- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Calego International Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for handwashing to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIAL HAND- 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._
----------
ANTIBACTERIAL HAND GEL
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl Alcohol 75%
_PURPOSE_
Antibacterial
_USE_
for handwashing to decrease bacteria on the skin
_WARNINGS_
FOR EXTERNAL USE ONLY.
DO NOT USE
in the eyes
STOP USE AND ASK A DOCTOR IF
irritation and redness develop
condition persists for more than 72 hours
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
_DIRECTIONS_
wet hands thoroughly with product and allow to dry without wiping
_INACTIVE INGREDIENTS_
Aqua, Capom, Triethanolamine
_QUESTIONS OR COMMENTS?_
To report a serious adverse event, contact 1-800-334-4577
PACKAGE LABELING: 60ML (72487-006-02)
PACKAGE LABELING: 30ML (72487-006-01)
ANTIBACTERIAL HAND
alcohol gel
Calego International Inc.
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7248 7-0 0 6
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)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7248 7-0 0 6 -0 2
6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct
0 5/0 1/20 20
2
NDC:7248 7-0 0 6 -0 1
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 CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333E
0 5/0 1/20 20
LABELER -
Calego International Inc. (081320445)
Revised: 5/2020