OTC Medication Information: Triple Power Pain Relief

TRIPLE POWER PAIN RELIEF- menthol, unspecified form and camphor (synthetic) cream
Concept Laboratories, 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.

Drug Facts

Active ingredient Purpose
Menthol 12% Pain Relieving
Camphor 6% Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Extremely Flammable: Keep from heat and flame.

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
  • if pregnant or nursing, seek the advice of a health professional before using

Directions

  • Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock
  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Phenoxyethanol (Phenagon PDI), DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions or comments?

Call 1-888-373-8831 or visit us at www.conceptlabs.org

PRINCIPAL DISPLAY PANEL — 106 g Bottle Label

TRIPLE
POWER
PAIN RELIEF

SUPER COOLING
FAST ACTING

MENTHOL & CAMPHOR

+
ARNICA,
ROSEMARY
& ACAI

NET WT 3.75 OZ (106 g)

Principal Display Panel -- 106 g Bottle Label
(click image for full-size original)
TRIPLE POWER PAIN RELIEF
menthol, unspecified form and camphor (synthetic) cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-341
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 0.12 g in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 0.06 g in 1 g
Inactive Ingredients
Ingredient Name Strength
Water
ALOE VERA LEAF
PROPYLENE GLYCOL
PEPPERMINT OIL
ALCOHOL
STARCH, CORN
ARNICA MONTANA FLOWER
LINSEED OIL
ROSEMARY OIL
ACAI OIL
PPG-2 HYDROXYETHYL COCAMIDE
METHYL DIISOPROPYL PROPIONAMIDE
ETHYL MENTHANE CARBOXAMIDE
MENTHYL LACTATE, (-)-
LAURYL LAURATE
DMDM HYDANTOIN
PHENOXYETHANOL
IODOPROPYNYL BUTYLCARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64058-341-64 106 g in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 06/25/2015
Labeler — Concept Laboratories, Inc. (962282612)
Establishment
Name Address ID/FEI Operations
Concept Laboratories, Inc. 962282612 MANUFACTURE (64058-341)

Revised: 06/2015 Concept Laboratories, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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