DOLORAN- menthol, camphor, methyl salicylate ointment 
Hector Rivera Garzon y Compania. S. en C.

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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Active Ingredients

Active Ingredients Purpose

Menthol _______________________________ 2.0% Topical Analgesic

Camphor ______________________________ 8.0% Topical Analgesic

Methyl Salicylate_________________________ 8.0% Topical Analgesic

Purpose

Topical Analgesic

Use

Temporarily relieves the minor aches and pains of muscles and joints associated with:

Warnings

For external use only

Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of htis product and consult a doctor. Do not apply to wounds or damaged skin. Do not bandage tightly

Keep out of reach of children to avoid accidental ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Inactive Ingredients (Petrolatum, anhydrous lanolin, parrafin)

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DOLORAN 
menthol, camphor, methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71016-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.08 g  in 1 g
CAMPHOR, (-)- (UNII: 213N3S8275) (CAMPHOR, (-)- - UNII:213N3S8275) CAMPHOR, (-)-0.08 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
Color    Score    
ShapeROUNDSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71016-001-201 in 1 BOX10/24/2016
120 g in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/24/2016
Labeler - Hector Rivera Garzon y Compania. S. en C. (881238799)

Revised: 12/2019
Document Id: 9ab28852-3e33-308b-e053-2a95a90ae192
Set id: 3dbdca24-10ee-3f5b-e054-00144ff88e88
Version: 5
Effective Time: 20191227
 
Hector Rivera Garzon y Compania. S. en C.