DOLORAN- menthol, camphor, methyl salicylate ointment

Doloran by

Drug Labeling and Warnings

Doloran by is a Otc medication manufactured, distributed, or labeled by Hector Rivera Garzon y Compania. S. en C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

• Do not use​ on wounds or damaged skin with a healing pad
• Do not use on a child under 12 years of age with arthritis-like conditions

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

Keep out of reach of children to avoid accidental ingestion.

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

Directions

• Use only as directed
• Adults and children 12 years of age and older; apply to affected area not ore than 3 to 4 times daily
• Children under 12 years of age; ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients (Petrolatum, anhydrous lanolin, parrafin)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLORAN 
menthol, camphor, methyl salicylate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71016-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.08 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 SALICYLATE	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color		Score
Shape	ROUND	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71016-001-20	1 in 1 BOX	10/24/2016
1		20 g in 1 BOX; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/24/2016

Labeler - Hector Rivera Garzon y Compania. S. en C. (881238799)