Label: COMPOUND W- salicylic acid gel
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-348-07 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 63029-595
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 4, 2017
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
Flammable. Keep away from fire and flame.
Do not use
- on irritated skin or on any area that is infected or reddened.
- on moles, birthmarks, warts with hair growing from them, genital warts or warts on the face or mucous membranes.
- if you have diabetes or poor blood circulation.
- on irritated skin or on any area that is infected or reddened.
- Directions
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 7 gm Tube Box Label
CommUnityCare Federally Qualified Health Centers
COMPOUND
W GEL 7 GMDate:
Name:
Dr.APPLY 1 DROP TO CLEAN, DRY WART 1-2 TIMES DAILY.
REPEAT UP TO 12 WEEKS.1-1-11
123456
Compound W GEL 7gm NDC 76413-348-07
Batch: 123456
Lot: 123456
Exp: 1-1-11
MEDTECHFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
COMPOUND W
salicylic acid gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-348(NDC:63029-595) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.17 g in 7 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CAMPHOR (NATURAL) (UNII: N20HL7Q941) CASTOR OIL (UNII: D5340Y2I9G) ETHYL ACETATE (UNII: 76845O8NMZ) HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P) HYPOPHOSPHOROUS ACID (UNII: 8B1RL9B4ZJ) ISOPROPYL ALCOHOL (UNII: ND2M416302) PYROXYLIN (UNII: KYR8BR2X6O) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-348-07 1 in 1 BOX 11/30/2017 1 7 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358B 03/15/2014 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-348) , RELABEL(76413-348)