- Active Ingredient
- Uses
- Purpose
- Warnings
- Other Information
- Directions
- 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
- PRINCIPAL DISPLAY PANEL
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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)