Label: AMMENS MEDICATED POWDER SHOWER FRESH FORMULA- zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 41595-1059-2 - Packager: Idelle Labs, Ltd
- 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.
Drug Label Information
Updated May 21, 2013
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- SPL UNCLASSIFIED SECTION
- Active Ingredient:
- Purpose:
- Uses:
- Warning:
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions:
- Other Information:
- Inactive Ingredients:
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMMENS MEDICATED POWDER SHOWER FRESH FORMULA
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41595-1059 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 9.1 g in 100 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) ISOSTEARIC ACID (UNII: X33R8U0062) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41595-1059-2 312 g in 1 CANISTER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 02/01/2003 Labeler - Idelle Labs, Ltd (128822926) Registrant - Idelle Labs, Ltd (128822926) Establishment Name Address ID/FEI Business Operations PTI Union, LLC 807308858 MANUFACTURE(41595-1059) Establishment Name Address ID/FEI Business Operations MK Packaging Inc. 047022405 MANUFACTURE(41595-1059)