Label: TRIUMPH DAILY MD- camphor 3% menthol 15% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 73646-001-01 - Packager: Dolotech inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 17, 2020
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- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
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.
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WARNINGS
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.
- DOSAGE & ADMINISTRATION
- Other information
- Inactive ingredients
- Product Label
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INGREDIENTS AND APPEARANCE
TRIUMPH DAILY MD
camphor 3% menthol 15% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73646-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 30 mg in 1 mL RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL 150 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:73646-001-01 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/20/2020 Labeler - Dolotech inc. (204095785) Establishment Name Address ID/FEI Business Operations Delta Pharma Inc. 200161730 manufacture(73646-001)