SPL v3
SPL
SPL Set ID 1b6f929a-db65-8a02-e063-6394a90a8b59
Route
TOPICAL
Published
Effective Date 2004-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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 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

Camphor 3% & Menthol 3%

PAIN RELIEVING CREAM

GOLDEN TIGER

with Arnica & Ginger

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 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)

Camphor 3% & Menthol 3%

PAIN RELIEVING CREAM

GOLDEN TIGER

with Arnica & Ginger

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

All Sections (JSON)