DOCTORRELIEF- menthol patch 
Biotanico Inc.

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.

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DoctorRelief

Actives

Active ingredients Purpose
Menthol 50 mg patch............................................Topical analagesic

Topical analgesic

Indication 

Uses
Temporary relief minor aches and pains of muscles and joints associated with:
■Arthritis ■Bruises ■Simple backache ■Strains ■Sprains

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

Stop use and ask a doctor if
■ Rash, itching or excessive skin irritation develops
■ Condition worsens or does not improve after regular use
■ Symptoms persist for more than 7 days or clear up and occur again within a few days

OTC-Keep out of reach of children

**Keep out of reach of children**
If swallowed, get medical help or contact a Poison Control Center immediately

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

Rosin,Rinus(Ricinus communis),zinc oxide,Clematis chinensis root,Bee'wax,Myrrh(calcined),Mastic(calcined),Cochinchina momordica seed, Methyl salicylate,Indigo carmine(F,D&C# Blue),F,D&C #Yellow and Q.S with sesame oil to 1g

Storage and handling section

Image of DoctorRelief LabelImage of DoctorRelief Label

DOCTORRELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57842-7734
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol50 mg
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (FD&C YELLOW NO. 5) , blue (FD&C BLUE NO. 2) , red (FD&C RED NO. 40) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57842-7734-110 in 1 CARTON; Type 0: Not a Combination Product02/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/03/2018
Labeler - Biotanico Inc. (658835665)
Registrant - Biotanico Inc. (658835665)
Establishment
NameAddressID/FEIBusiness Operations
Biotanico Inc.658835665manufacture(57842-7734)

Revised: 3/2018
Document Id: 81b7cc05-7578-4e7b-9b9d-d0aebcbcab77
Set id: 149b1382-5b3a-4390-9ce6-74cdbf3d3984
Version: 1
Effective Time: 20180327
 
Biotanico Inc.