Label: BUDPAK MEDICATED ANTI ITCH- camphor and menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 27293-027-01, 27293-027-28 - Packager: Budpak Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 6, 2013
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BUDPAK MEDICATED ANTI ITCH
camphor and menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-027 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.01 g in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) MINERAL OIL (UNII: T5L8T28FGP) STEARETH-21 (UNII: 53J3F32P58) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARETH-2 (UNII: V56DFE46J5) ALCOHOL (UNII: 3K9958V90M) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:27293-027-01 1 in 1 BOX 1 NDC:27293-027-28 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/17/2012 Labeler - Budpak Inc. (183224849) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(27293-027)