Camphor, Menthol Ointment [Active & Innovative Inc.] -

CAMPHOR, MENTHOL OINTMENT [ACTIVE & INNOVATIVE INC.]
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NDC	50421-004-34
Set ID	01b6a7e7-151e-4f6c-8934-c22806da4866
Category	HUMAN OTC DRUG LABEL
Packager	Active & Innovative Inc.
Generic Name
Product Class
Product Number
Application Number	PART348

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Active Ingredients (% by weight)

Camphor4.0%
Menthol 4.0%
Purpose

Analgesic (pain relief)
Uses

For the 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.
- Avoid getting into eyes or on mucous membranes.
- If the conditions worsens, or if the symptoms persists for more than 7 days or clears up and occurs 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.
OTC - Keep Out of Reach of Children Section

Keep out of reach of children.
Other Warnings
- 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: Rub this soothing cream on the affected area not more that 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

Caprylyl glycol, cetyl alcohol, chondroitin sulphate, eucalyptus oil, glucosamine sulfate, glycerin, glycol stearate, grape seed oil, C13-14 isoparaffin, Laureth-7, lavender oil, methylsulfonyl-methane (MSM), phenoxyethanol, polyacrylamide, polysorbate-20, sea cucumber extract, sorbic acid, stearyl alcohol, thymol, urea, Vitamin E (tocopheral acetate), water, wintergreen oil.
Questions?

Questions? 416-967-3746
Principal Display Panel

PROFESSIONAL THERAPY        MAXIMUM STRENGTH

                                                  MAXIMA POTENCIA

MuscleCare TM

PAIN RELIEVING OINTMENT/ POMADA ALIVIANTE DEL DOLOR

                                                  by / por el Dr. Chris Oswald

    FOR
MUSCLE
& JOINT
PAIN RELIEF

   PARA EL
ALIVIO DEL
    DOLOR
MUSCULAR Y
ARTICULAR

GREASELESS ● STAINLESS ● SHAKE WELL BEFORE EACH USE

SIN GRASA ● NO MANCHA ● AGITAR BIEN ANTES DE CADA USO

NET WT Peso NETO 115g. (4oz.)

INGREDIENTS AND APPEARANCE

CAMPHOR, MENTHOL
camphor, menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50421-004
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (UNII: 5TJD82A1ET) (CAMPHOR - UNII:5TJD82A1ET)	CAMPHOR	4.6 g in 115 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4.6 g in 115 g

Ingredient Name	Strength
Inactive Ingredients
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETYL ALCOHOL (UNII: 936JST6JCN)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL STEARATE (UNII: 0324G66D0E)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAVENDER OIL (UNII: ZBP1YXW0H8)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBIC ACID (UNII: X045WJ989B)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
THYMOL (UNII: 3J50XA376E)
UREA (UNII: 8W8T17847W)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
WATER (UNII: 059QF0KO0R)
METHYL SALICYLATE (UNII: LAV5U5022Y)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50421-004-34	115 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part348	01/13/2010

Labeler - Active & Innovative Inc. (206978079)

Name	Address	ID/FEI	Business Operations
Establishment
International Laboratories (Canada) Ltd.		247010150	manufacture

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Medic

CAMPHOR, MENTHOL OINTMENT [ACTIVE & INNOVATIVE INC.]

OTC - Keep Out of Reach of Children Section

Other Warnings

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