TRIUMPH DAILY MD- camphor 3% menthol 15% spray 
Dolotech 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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Drug Facts

Active ingredients                                  Purpose
dl-Camphor 3% .......................................   Topical analgesic
dL-Menthol 15% ......................................... Topical analgesic

Uses

Temporarily relieves aches and pains of muscles and joints associated with one or more of the following:simple backache, lumbago, strains and sprains (involving muscles, tendons and /or ligaments) and arthritis.

Not recommended for emotional pain. Consult a healthcare practitioner / health care provider / health care professional / doctor / physician for use beyond 7 days.

Warnings
For external use only
• Avoid contact with the eyes and mucous membranes. Do ont use otherwise than as directed.

Caution: Discontinue use if excessive irritation of the skin develops.

When using this product

Do not apply to wounds or damaged skin.

Do not tightly bandage.

Do not apply with external heat, such as electric heating pad, as this may result in excessive skin irritation or skin burn.

Do not inhale.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if • Hypersensitivity  / allergy, rashes and or burning discomfort occur. • You experience pain, swelling or blistering. •Symptoms worsens •Symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Seek immediate medical help or contact a Poison Control Center immediately if overdose or accidental ingestion occurs.

Directions

Adults and children 12 years of age and older: 1 Spray 3-4 times per day. Apply thinly and evenly to affected area. Rub and / or massage into skin until solution vannishes.

Children under 12 years of age: Consult a doctor.

Other information

Inactive ingredients

beta-Alanine, Magnesium chloride, SDAG-3, Salix Nigra (Willow) Bark Extract, Aqua (Water), Glycerin, Potassium chloride.

Product Label

image

TRIUMPH DAILY MD 
camphor 3% menthol 15% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73646-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 mL
RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL150 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WILLOW BARK (UNII: S883J9JDYX)  
SALIX ALBA BARK (UNII: 205MXS71H7)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
.BETA.-ALANINE (UNII: 11P2JDE17B)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73646-001-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/20/2020
Labeler - Dolotech inc. (204095785)
Establishment
NameAddressID/FEIBusiness Operations
Delta Pharma Inc.200161730manufacture(73646-001)

Revised: 2/2020
Document Id: c8ba7005-a8ee-417c-8015-be2a416cdc42
Set id: da2e00c8-b60b-4ff2-a5d1-5467d6ee2db4
Version: 1
Effective Time: 20200217
 
Dolotech inc.