Label: MR DUDLEYS TOPICAL PAIN RELIEF- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58484-100-01, 58484-100-05, 58484-100-20, 58484-100-45 - Packager: DUDLEY WELLNESS COMPANY 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 May 10, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- Uses:
- KEEP OUT OF REACH OF CHILDREN
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Warnings:
- For external use only.
- Use only as directed.
- Do not apply to wounds or damaged skin.
- If redness is present, discontinue use and consult a doctor.
- Do not bandage tightly or use a heating pad.
- If the condition persists for more than 5 days, discontinue use and consult a doctor.
- Avoid contact with eyes and other mucous membranes.
- If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.
- Directions:
- Inactive Ingredients:
- Product Label
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INGREDIENTS AND APPEARANCE
MR DUDLEYS TOPICAL PAIN RELIEF
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58484-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) METHYL SALICYLATE (UNII: LAV5U5022Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ACRYLAMIDE (UNII: 20R035KLCI) EUGENOL (UNII: 3T8H1794QW) METHYL EUGENOL (UNII: 29T9VA6R7M) NUTMEG OIL (UNII: Z1CLM48948) METHYL ISOEUGENOL (UNII: 46RN7Q97DE) 4-ALLYL-2,6-DIMETHOXYPHENOL (UNII: 8VF00YWP89) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58484-100-01 .2 g in 1 BOTTLE 2 NDC:58484-100-05 1.4 g in 1 BOTTLE 3 NDC:58484-100-20 57 g in 1 BOTTLE 4 NDC:58484-100-45 128 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 05/13/2013 Labeler - DUDLEY WELLNESS COMPANY INC (078816740) Establishment Name Address ID/FEI Business Operations DUDLEY MANUFACTURING LLC. 830613076 manufacture(58484-100)