QUALITY CHOICE BACITRACIN- bacitracin ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)

Available from:

CHAIN DRUG MARKETING ASSOCIATION INC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses first aid to help prevent infection in - minor cuts - scrapes - burns Do not use - in the eyes - if you are allergic to any of the ingredients - over large areas of the body - longer than 1 week unless directed by a doctor Stop use and ask a doctor if - the condition persists or gets worse - a rash or other allergic reaction develops Directions - clean the affected area - apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily - may be covered with a sterile bandage

Authorization status:

OTC monograph final

Summary of Product characteristics

QUALITY CHOICE BACITRACIN- BACITRACIN OINTMENT
CHAIN DRUG MARKETING ASSOCIATION 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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ACTIVE INGREDIENTS (EACH GRAM CONTAINS) PURPOSE
Bacitracin 500 units
.......................................................................................First
Aid Antibiotic
US ES
first aid to help prevent infection in
minor cuts
scrapes
burns
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
in the eyes
if you are allergic to any of the ingredients
over large areas of the body
longer than 1 week unless directed by a doctor
ASK A DOCTOR BEFORE USE in case of deep or puncture wounds, animal
bites, or serious burns
STOP USE AND ASK A DOCTOR IF
the condition persists or gets worse
a rash or other allergic reaction develops
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away
DIRECTIONS
clean the affected area
apply a small amount of this product (an amount equal to the surface
area of the tip of a finger) on the
area 1 to 3 times daily
may be covered with a sterile bandage
OTHER INFORMATION
store at 15 to 25 C (59 to 77 F)
Lot No. and Exp. Date: see box or see crimp of tube
INACTIVE INGREDIENTS
aloe vera gel, light mineral oil and white petrolatum
DISTRIBUTED BY
C.D.M.A., Inc
NOVI, MI 48376-0995
MADE IN KOREA
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QUALITY CHOICE BACITRACIN
bacitracin ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 38 6 8 -9 6 0
CHAIN DRUG MARKETING ASSOCIATION INC
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BACITRACIN (UNII: 58 H6 RWO52I) (BACITRACIN - UNII:58 H6 RWO52I)
BACITRACIN
50 0 [USP'U] in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
MINERAL O IL (UNII: T5L8 T28 FGP)
PETRO LATUM (UNII: 4T6 H12BN9 U)
PACKAG ING
#
ITEM CODE
PACKAGE D