SPL v4
SPL
SPL Set ID 1cd37b69-2cfb-130d-e063-6394a90af50b
Route
TOPICAL
Published
Effective Date 2004-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3 mg) Menthol
Inactive Ingredients
Sodium Hydroxide Ananas Sativus (pineapple) Fruit Rosa Centifolia Flower Benzoic Acid Propylene Glycol Decyl Glucoside Dimethyl Sulfone Vitis Vinifera Seed Sorbic Acid Salix Alba Bark Frankincense Ginger Aloe Vera Leaf Phenoxyethanol Hamamelis Virginiana Top Water Glycerin Water Carbomer Homopolymer, Unspecified Type Arnica Montana Flower Capsicum Camellia Sinensis Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-12-02

Description

Camphor 3% Menthol 3%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Camphor 3% Menthol 3%

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • sprains
  • bruises
  • strains
Section 43683-2
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a physician
  • wash hands after use with cool water

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product

  • use only as directed
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use

Section 51945-4

Pain Wizard

PAIN RELIEVING CREAM

Camphor 3% & Menthol 3%

Relief for Muscular & Arthritic Pain

with Arnica & MSM

16 FL OZ / 473.17 ML

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Warnings

For external use only

Directions
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a physician
  • wash hands after use with cool water
Other Information
  • store at 20-25°C (68-77°F)
  • store in a cool, dry place away from direct sunlight
Active Ingredients

Camphor 3%

Menthol 3%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Arnica Montana Flower Extract, Benzoic Acid, Boswellia Carterii Resin Extract, Camellia Sinensis Flower Extract, Capsicum Annuum Extract, Carbomer, Decyl Glucoside, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Methyl Sulfonyl Methane, Phenoxyethanol, Propylene Glycol, Rosa Centifolia Flower Extract, Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sorbic Acid, Vitis Vinifera (Grape) Seed Extract, Water, Zingiber Officinale (Ginger) Root Extract


Structured Label Content

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • sprains
  • bruises
  • strains
Section 43683-2 (43683-2)
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a physician
  • wash hands after use with cool water

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • avoid contact with the eyes and mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use

Section 51945-4 (51945-4)

Pain Wizard

PAIN RELIEVING CREAM

Camphor 3% & Menthol 3%

Relief for Muscular & Arthritic Pain

with Arnica & MSM

16 FL OZ / 473.17 ML

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Topical Analgesic

Warnings

For external use only

Directions
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a physician
  • wash hands after use with cool water
Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • store in a cool, dry place away from direct sunlight
Active Ingredients (Active ingredients)

Camphor 3%

Menthol 3%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Arnica Montana Flower Extract, Benzoic Acid, Boswellia Carterii Resin Extract, Camellia Sinensis Flower Extract, Capsicum Annuum Extract, Carbomer, Decyl Glucoside, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Methyl Sulfonyl Methane, Phenoxyethanol, Propylene Glycol, Rosa Centifolia Flower Extract, Salix Alba (Willow) Bark Extract, Sodium Hydroxide, Sorbic Acid, Vitis Vinifera (Grape) Seed Extract, Water, Zingiber Officinale (Ginger) Root Extract


Advanced Ingredient Data


Raw Label Data

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