Label: BACITRACIN ointment
Contains inactivated NDC Code(s)
NDC Code(s): 50382-005-01, 50382-005-02, 50382-005-03, 50382-005-04
- Packager: Galentic Pharma (India) Priva Te Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated August 6, 2013
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- ACTIVE INGREDIENT
For external use only
Dosage and Administration
- clean the affected areas
- apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
- may be covered with a sterile bandage
Stop Use and ask a doctor if:
- the condition persists or gets worse, or if a rash or other allergic reaction develops.
Do Not Use if:
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
- longer than 1 week unless directed by a doctor
- Ask a doctor before use:
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-005-01 28.35 g in 1 TUBE 2 NDC:50382-005-02 14.17 g in 1 TUBE 3 NDC:50382-005-03 56.7 g in 1 TUBE 4 NDC:50382-005-04 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/02/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Priva Te Limited 918531450 manufacture(50382-005)