Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8d0e57fe-6384-4cb1-aefb-25dc02dbf673
Route
TOPICAL
Published
Effective Date 2013-05-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g) Camphor (natural) (11 g) Salicylic Acid
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cetostearyl Alcohol Ceteth-10 Phosphate Dihexadecyl Phosphate Glucosamine Sulfate Phenoxyethanol Trolamine Glycerin Sunflower Oil Cyclomethicone Isopropyl Palmitate Dimethyl Sulfone Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-05-24

Description

Camphor 4%, Menthol 4%, Methyl Salicylate 11%


Medication Information

Warnings and Precautions

Warnings

For external use only. Use only as directed.  Do not use on wounds or damaged skin.  When using this product avoid contact with eyes and mucous membranes, do not bandage tightly.  Stop use and consult doctor if condition worsens or symptoms persist for more than 7 days or symptoms clear up and occur again within a few days. 

Indications and Usage

Uses

Temporarily relieves minor muscle pain, joint pain.  Temporarily relieves pain associated with:  arthritis pain, backache, strains, sprains, and bruises.

Dosage and Administration

Directions

Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

Description

Camphor 4%, Menthol 4%, Methyl Salicylate 11%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive ingredients

Acrylates C10-30 alkyl acrylate crosspolymer, Water, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Phenoxyethanol, Triethanolamine.

Section 51945-4

Iampur Pain Relief Massager

Pain Relieving Gel





Section 55105-1

Purpose

Topical Analgesic.



Section 55106-9

Camphor 4%, Menthol 4%, Methyl Salicylate 11%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor muscle pain, joint pain.  Temporarily relieves pain associated with:  arthritis pain, backache, strains, sprains, and bruises.

Dosage and Administration (34068-7)

Directions

Adults and children 12 years of age and older:  use no more than 3 to 4 times daily.  Apply cream to affected  areas and thoroughly massage until penetrated.  Wash hands with soap and water after use.

Warnings and Precautions (34071-1)

Warnings

For external use only. Use only as directed.  Do not use on wounds or damaged skin.  When using this product avoid contact with eyes and mucous membranes, do not bandage tightly.  Stop use and consult doctor if condition worsens or symptoms persist for more than 7 days or symptoms clear up and occur again within a few days. 

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive ingredients

Acrylates C10-30 alkyl acrylate crosspolymer, Water, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Phenoxyethanol, Triethanolamine.

Section 51945-4 (51945-4)

Iampur Pain Relief Massager

Pain Relieving Gel





Section 55105-1 (55105-1)

Purpose

Topical Analgesic.



Section 55106-9 (55106-9)

Camphor 4%, Menthol 4%, Methyl Salicylate 11%


Advanced Ingredient Data


Raw Label Data

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