SPL v1
SPL
SPL Set ID ed7ee9b0-c64f-4c46-a08f-dc47fe73c381
Route
TOPICAL
Published
Effective Date 2014-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Carbomer 940 Cetyl Alcohol Trolamine Water Stearic Acid Oleth-3 Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-12-15

Description

Menthol - 10% Methyl salicylate - 15%

Purpose

Topical Analgesic Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Topical Analgesic

Description

Menthol - 10% Methyl salicylate - 15%

Uses

Temporary relief of minor aches and pains of muscle and joints associated with

  • simple back aches
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For external use only

Do not use

  • on wounds, damaged, broken or irritated skin
  • with a heating pad

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • Do not apply bandage tightly

Stop use and ask doctor if

  • Condition worsens, or symtoms persist for more than 7 days
  • symptoms  clear up and occur again within a few days
  • excessive skin irritation occurs
  • If pregnant or breast feeding, ask a health professional before use.
Directions
  • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age; consult a doctor.
Other Information
  • Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
  • Close cap tightly after use.
Active Ingredients

Menthol - 10%

Methyl salicylate - 15%

Inactive Ingredients

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Purified Water, Stearic acid, Triethanolamine

Principal Display Panel 3.0 Oz Tube

RAY DOL

Pain Relieving Cream

Topical Analgesic

Net WT. 3.0 oz (85g)

Principal Display Panel 3.0 Oz Carton

RAY DOL

Topical Analgesic

Greaselees Stainless

Temporary Relief

Penetrating temporary relief of minor muscle aches

For Arthritis, Muscle & Joint Pain

10% Menthol and

15% Methyl Salicylate

Net WT. 3.0 oz ( 85g)


Structured Label Content

Uses

Temporary relief of minor aches and pains of muscle and joints associated with

  • simple back aches
  • arthritis
  • strains
  • bruises
  • sprains
Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Purpose

Topical Analgesic

Topical Analgesic

Warnings

For external use only

Do not use

  • on wounds, damaged, broken or irritated skin
  • with a heating pad

When using this product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • Do not apply bandage tightly

Stop use and ask doctor if

  • Condition worsens, or symtoms persist for more than 7 days
  • symptoms  clear up and occur again within a few days
  • excessive skin irritation occurs
  • If pregnant or breast feeding, ask a health professional before use.
Directions
  • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age; consult a doctor.
Other Information (Other information)
  • Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
  • Close cap tightly after use.
Active Ingredients

Menthol - 10%

Methyl salicylate - 15%

Inactive Ingredients (Inactive ingredients)

Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Purified Water, Stearic acid, Triethanolamine

Principal Display Panel 3.0 Oz Tube (Principal Display Panel - 3.0 oz Tube)

RAY DOL

Pain Relieving Cream

Topical Analgesic

Net WT. 3.0 oz (85g)

Principal Display Panel 3.0 Oz Carton (Principal Display Panel - 3.0 oz Carton)

RAY DOL

Topical Analgesic

Greaselees Stainless

Temporary Relief

Penetrating temporary relief of minor muscle aches

For Arthritis, Muscle & Joint Pain

10% Menthol and

15% Methyl Salicylate

Net WT. 3.0 oz ( 85g)


Advanced Ingredient Data


Raw Label Data

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