BACITRACIN ointment

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

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Download 제품 특성 요약 (SPC)
15-01-2018

유효 성분:

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

제공처:

Denison Pharmaceuticals, Inc.

INN (국제 이름):

BACITRACIN

구성:

BACITRACIN 500 [USP'U] in 1 g

처방전 유형:

OTC DRUG

승인 상태:

OTC monograph final

제품 특성 요약

                                BACITRACIN- BACITRACIN OINTMENT
DENISON PHARMACEUTICALS, 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._
----------
BACITRACIN
ACTIVE INGREDIENT
Bacitracin 500 units per gram.
PURPOSE
First aid antibiotic.
INDICATIONS
First aid to help prevent infection in minor cuts, scrapes, and burns.
WARNINGS
For external use only. Do not use in the eyes or apply over large
areas of the body. In case of deep
puncture wounds, animal bites, or serious burns, consult a doctor.
STOP USE AND CONSULT A DOCTOR
if the condition persists or gets worse, or if a rash or other
allergic reaction develops. Do not use if
you are allergic to any of the ingredients. Do not use longer than one
week unless directed by a doctor.
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
After gentle washing, apply a small amount (an amount equal to the
surface area of the tip of a finger)
directly to the affected areas and cover with sterile gauze if
desired. May be applied 1 to 3 times daily
as the condition indicates.
In case of accidental ingestion, seek professional assistance or
contact a Poison Control Center
immediately.
INACTIVE INGREDIENTS
ALSO CONTAINS
Mineral oil, white petrolatum
STORAGE
Store in controlled room temperature 59°-88°F (15°-30°C).
PRINCIPAL DISPLAY PANEL
NDC 0295-1223-95
BACITRACIN OINTMENT U.S.P.
First Aid Antibiotic
NET WT. 1 OZ. (28.35g)
BACITRACIN
bacitracin ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 29 5-1223
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
MINERAL O IL (UNII: T5L8 T28 FGP)
PETRO LATUM (UNII: 4T6 H12BN9 U)
Denison Pharmaceuticals, Inc.
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING
                                
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