Label: POMADA SULFA FIRST AID ANTIBIOTIC- neomycin sulfate ointment
- NDC Code(s): 48201-103-11
- Packager: Grandall Distributing Co., Inc.
- This is a repackaged label.
- Source NDC Code(s): 52137-2924
- 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 January 6, 2022
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- ACTIVE INGREDIENT
For external use only. Do not use in the eyes or over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a doctor. Stop use and consult a doctor if condition persists or gets worse. Do not use longer than one week unless directed by a doctor. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Store at room temperature.
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
POMADA SULFA FIRST AID ANTIBIOTIC
neomycin sulfate ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48201-103(NDC:52137-2924) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48201-103-11 40 g in 1 JAR; Type 0: Not a Combination Product 02/06/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 02/06/2020 Labeler - Grandall Distributing Co., Inc. (044428324)