Doloflex Pain Relief by United Health & Beauty Corp / Maximsuramerica SAS Doloflex Pain Relief

Doloflex Pain Relief by

Drug Labeling and Warnings

Doloflex Pain Relief by is a Otc medication manufactured, distributed, or labeled by United Health & Beauty Corp, Maximsuramerica SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOLOFLEX PAIN RELIEF- camphor, menthol, methyl salicylate gel 
United Health & Beauty Corp

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Doloflex Pain Relief

Camphor 1.5%, Menthol 2%, Methyl Salicylate 3

Topical Analgesic

Temporarily relieves the minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, sprains, and bruises.

For external use only.

Do not use on children under 12 years of age, with a heating pad (may blister skin), on wounds or damaged skin.

When using this product do not bandage tightly, avoid contact with the eyes or mucous membranes.

Stop use and ask a doctor if excessive irritation develops, symptoms last more than 7 days or clear up and occur again within a few days, condition worsens.

If swallowed, get medical help or contact a poison control center right away.

Adults and children 12 years of age or older: apply to affected area up to 3 to 4 times daily. Children under 12 years of age: consult a physician.

Water, alcohol, carbomer, DMDM Hydantoin, Iodopropynyl Butylcarbamate, PEG-40 Hydrogenated Caster Oil, Aesculus Hippocastanum Seed Extract, Centella Assiatica Leaf Extract, Arnica Montana Flowers Oil, Calendula Officinalis Flower Extract, Triethanolamine.

DOLOFLEX PAIN RELIEF 
camphor, menthol, methyl salicylate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85350-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	3 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PEG-40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
DMDM HYDANTOIN (UNII: BYR0546TOW)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85350-038-10	300 g in 1 JAR; Type 0: Not a Combination Product	03/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/17/2025	04/11/2025

Labeler - United Health & Beauty Corp (087150432)

Registrant - Maximsuramerica SAS (886586033)

Establishment
Name	Address	ID/FEI	Business Operations
Maximsuramerica SAS		886586033	manufacture(85350-038)

Revised: 4/2025

Document Id: 32a847d0-fa6f-4262-e063-6394a90a413e

34390-5

Set id: 308ba2cd-8aec-a26c-e063-6294a90a88a7

Version: 2

Effective Time: 20250413