Label: DOCTORRELIEF- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 57842-7734-1 - Packager: Biotanico Inc.
- Category: HUMAN OTC 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 March 27, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Actives
- PURPOSE
- Indication
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Warnings
For external use only
When using this product:
■ Use only as directed
■ Avoid contact with eyes ,mucous membranes or rashes
■ Do not apply to broken, wounded or damaged skin
■ Do not bandage or cover with any type of wrap except clothing
■ Do not use with a heating pad or apply external heat
■ Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower - Questons
- OTC-Keep out of reach of children
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Dosages
Directions
Adult and children 12 years of age and over
■ Clean and dry affected area
■ Open pouch and remove patch. If desired, cut patch to size
■ Peel off protective backing and apply sticky side to affected area
■ Apply to affected area not more than 3 times daily
■ Wash hands with soap after applying patch
Children under 12 years of age
■ Consult a doctor - Warning and Precautions
- Ask Doctor
- Inactives
- Storage and handling section
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCTORRELIEF
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57842-7734 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 50 mg Inactive Ingredients Ingredient Name Strength ROSIN (UNII: 88S87KL877) RICINUS COMMUNIS WHOLE (UNII: Q94QWM85RF) ZINC OXIDE (UNII: SOI2LOH54Z) CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU) YELLOW WAX (UNII: 2ZA36H0S2V) MYRRH (UNII: JC71GJ1F3L) PISTACIA LENTISCUS RESIN (UNII: 7446H202QW) MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD) METHYL SALICYLATE (UNII: LAV5U5022Y) INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SESAME OIL (UNII: QX10HYY4QV) QS-21 (UNII: 61H83WZX3U) Product Characteristics Color yellow (FD&C YELLOW NO. 5) , blue (FD&C BLUE NO. 2) , red (FD&C RED NO. 40) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57842-7734-1 10 in 1 CARTON; Type 0: Not a Combination Product 02/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 01/03/2018 Labeler - Biotanico Inc. (658835665) Registrant - Biotanico Inc. (658835665) Establishment Name Address ID/FEI Business Operations Biotanico Inc. 658835665 manufacture(57842-7734)