Label: FREDS MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11383-265-51 - Packager: Weeks and Leo, 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 April 15, 2019
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- Active Ingredient
- Uses
- Purpose
- Warnings
- Other Information
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- DOSAGE & ADMINISTRATION
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Inactive Ingredients
aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum
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INGREDIENTS AND APPEARANCE
FREDS MEDICATED ANTI ITCH
pramoxine hydrochloride, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11383-265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 g in 100 g Inactive Ingredients Ingredient Name Strength STEARETH-21 (UNII: 53J3F32P58) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) SODIUM ACRYLATE (UNII: 7C98FKB43H) MINERAL OIL (UNII: T5L8T28FGP) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYL SALICYLATE (UNII: LAV5U5022Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q) EUCALYPTUS OIL (UNII: 2R04ONI662) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11383-265-51 1 in 1 CARTON 04/13/2014 1 28 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 not final part348 04/13/2014 Labeler - Weeks and Leo, Inc. (005290028) Registrant - Weeks and Leo, Inc. (005290028) Establishment Name Address ID/FEI Business Operations Weeks & Leo, Inc. 005290028 manufacture(11383-265)