Label: PAIN GOODBYE MEDICATED CREAM- menthol 5% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 15667-5049-4 - Packager: Austin Biotechnology Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated October 10, 2013
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- WARNINGS
- WARNINGS
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- DIRECTION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN GOODBYE MEDICATED CREAM
menthol 5% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:15667-5049 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14 g in 280 g Inactive Ingredients Ingredient Name Strength PEPPERMINT OIL (UNII: AV092KU4JH) EUCALYPTUS OIL (UNII: 2R04ONI662) LAVENDER OIL (UNII: ZBP1YXW0H8) JASMINE LACTONE (UNII: H8558L43SR) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CARBOMER 1342 (UNII: 809Y72KV36) CLOVE OIL (UNII: 578389D6D0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:15667-5049-4 280 g in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/26/2011 Labeler - Austin Biotechnology Inc (656001949) Registrant - Austin Biotechnology Inc (656001949) Establishment Name Address ID/FEI Business Operations Austin Biotechnology Inc 656001949 manufacture(15667-5049)