Label: FAST RELIEF REUMACETIN- menthol, methyl salicylate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 49283-512-08 - Packager: Chemco Corporation
- 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 August 26, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Uses
- Warnings:
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or mucous membranes. If condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days, or redness is present, or in conditions affecting children under 12 years of age, discontinue use and consult a physician immediately.
- Directions
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Inactive Ingredients:
AQUA, PARAFFINUM LIQUIDUM, STEARIC ACID, GLYCERYL MONOSTEARATE, CETYL ALCOHOL, DIMETHICONE, GLYCERETH-26, PROPYLENE GLYCOL, DIAZOLIDINYL UREA, METHYLPARABEN, PROPYLPARABEN, STEARYL ALCOHOL, TRIETHANOLAMINE, ACRYLAMIDE, SODIUM ACRYLATE, TRIDECETH-6, SODIUM HYALURONATE, SODIUM PCA, WHEAT AMINO ACIDS, PANTHENOL, SYMPHYTUM OFFICINALE EXTRACT, HYDROXYPROLINE.
- Manufactured by:
- FAST RELIEF REUMACETIN
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INGREDIENTS AND APPEARANCE
FAST RELIEF REUMACETIN
menthol, methyl salicylate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49283-512 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 7.5 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) STEARIC ACID (UNII: 4ELV7Z65AP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERETH-26 (UNII: NNE56F2N14) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) TROLAMINE (UNII: 9O3K93S3TK) ACRYLAMIDE (UNII: 20R035KLCI) SODIUM ACRYLATE (UNII: 7C98FKB43H) TRIDECETH-6 (UNII: 3T5PCR2H0C) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) AMINO ACIDS, WHEAT (UNII: 0370GZL32F) PANTHENOL (UNII: WV9CM0O67Z) COMFREY LEAF (UNII: DG4F8T839X) HYDROXYPROLINE (UNII: RMB44WO89X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49283-512-08 226 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 08/26/2013 Labeler - Chemco Corporation (032495954) Registrant - Chemco Corporation (032495954) Establishment Name Address ID/FEI Business Operations Chemco Corporation 032495954 manufacture(49283-512)