Label: MEDROX-RX- methyl salicylate, menthol, capsaicin ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 45861-005-01 - Packager: Pharmaceutica North America, Inc.
- Category: HUMAN PRESCRIPTION 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 October 27, 2011
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INGREDIENTS AND APPEARANCE
MEDROX-RX
methyl salicylate, menthol, capsaicin ointmentProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45861-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength methyl salicylate (UNII: LAV5U5022Y) (methyl salicylate - UNII:LAV5U5022Y) methyl salicylate 24 g in 120 g menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 8.4 g in 120 g capsaicin (UNII: S07O44R1ZM) (capsaicin - UNII:S07O44R1ZM) capsaicin 0.6 g in 120 g Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CETYL ALCOHOL (UNII: 936JST6JCN) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEG-150 DISTEARATE (UNII: 6F36Q0I0AC) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TROLAMINE (UNII: 9O3K93S3TK) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:45861-005-01 120 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/27/2011 Labeler - Pharmaceutica North America, Inc. (962739699) Registrant - Pharmaceutica North America, Inc. (962739699) Establishment Name Address ID/FEI Business Operations Pure Source 969241041 manufacture