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NDC 70039-0283-07 Professional Therapy MuscleCare pain relieving gel 40; 100 mg/g; mg/g Details

Professional Therapy MuscleCare pain relieving gel 40; 100 mg/g; mg/g

Professional Therapy MuscleCare pain relieving gel is a CUTANEOUS; TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Active and Innovative Inc.. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	70039-0283
Product ID	70039-283_39bd979f-91a1-0554-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Professional Therapy MuscleCare pain relieving gel
Proprietary Name Suffix	Extra Strength
Non-Proprietary Name	Camphor, Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	CUTANEOUS; TOPICAL
Active Ingredient Strength	40; 100
Active Ingredient Units	mg/g; mg/g
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL
Labeler Name	Active and Innovative Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70039-0283-07 (70039028307)

Pricing Information	N/A
NDC Package Code	70039-283-07
Billing NDC	70039028307
Package	1 g in 1 BOTTLE, WITH APPLICATOR (70039-283-07)
Marketing Start Date	2015-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1d2403d9-99c3-24f5-e054-00144ff8d46c Details

Active Ingredients (% by weight) Purpose

Camphor 4.0%................................Analgesic (pain relief)

Menthol 10.0%.................................Analgesic (pain relief)

Uses:

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Warnings:

For external use only.

- Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes

- 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 this product and consult a doctor.

- Do not apply to wounds or damaged skin. Do not bandage tightly.

Keep out of reach of children.

- Use only as directed.

- Do not use if pregnant or breastfeeding.

- If swallowed, get medical help or contact a Poison Control center right away.

Directions:

Adults and children 12 years of age or older: Using the roll-on applicator massage a liberal amount of gel directly on the affected area not more than 3 to 4 times daily. Children under the age of 12: Do not use, consult a doctor.

Other Information:

Store under normal storage conditions. Store away from children.

Inactive Ingredients:

Alcohol Denat., Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint Oil), Propylene Glycol, Glycerin, MSM (Methylsulfonylmethane), Boswellia Serrata Extract, Ilex Paraguensis (Yerba Mate Ilex) Extract, Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine.

SPL UNCLASSIFIED SECTION

FOR MUSCLE & JOINT PAIN RELIEF

PRINCIPAL DISPLAY PANEL

Extra Strength Pain Relieving Gel

by Dr. Chris Oswald

Net Wt

3oz. (85g)

INGREDIENTS AND APPEARANCE

PROFESSIONAL THERAPY MUSCLECARE PAIN RELIEVING GEL EXTRA STRENGTH

camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70039-283
Route of Administration	CUTANEOUS, TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)
WATER (UNII: 059QF0KO0R)
EUCALYPTUS OIL (UNII: 2R04ONI662)
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
ALCOHOL (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70039-283-07	1 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/01/2015

Labeler - Active and Innovative Inc. (206978079)

Name	Address	ID/FEI	Business Operations
Establishment
PureTek Corp.		785961046	manufacture(70039-283)

Revised: 8/2016

Document Id: 39bd979f-91a1-0554-e054-00144ff8d46c

Set id: 1d2403d9-99c3-24f5-e054-00144ff8d46c

Version: 2

Effective Time: 20160810