Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f3d7d48b-adc4-4b3b-bbf3-0261a1a22d08
Route
TOPICAL
Published
Effective Date 2010-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Menthyl Salicylate (30 g) Camphor (natural) (4 g)
Inactive Ingredients
Edetate Disodium Glyceryl Monostearate Lanolin Polysorbate 80 Potassium Hydroxide Stearic Acid Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-16

Description

                        Camphor 4% Menthol 10% Methyl Salicylate 30%


Medication Information

Warnings and Precautions

For external use only.

Description

                        Camphor 4% Menthol 10% Methyl Salicylate 30%

Uses
temporarily relieves the minor aches and pains of muscle and joints associated with:

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains

Section 51945-4

Muscle Rub Ultra

Section 55105-1

Topical analgesic

Topical analgesic

Topical analgesic

Directions
  • Use only as directed
  • 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:  ask a doctor

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Questions?

call 1-800-883-0085, weekdays, 9AM -5PM PST

Other Information
  • Store at 20 ° to 25 ° C (68 ° to 77 °F)

Active Ingredients

                       

Camphor 4%

Menthol 10%

Methyl Salicylate 30%



Inactive Ingredients

carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Ask A Doctor Before Use If You Have

redness over the affected area

Keep Out of Reach of Children to Avoid Accidental Ingestion.

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


Structured Label Content

Uses
temporarily relieves the minor aches and pains of muscle and joints associated with:

  • simple bachache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings and Precautions (34071-1)

For external use only.

Section 51945-4 (51945-4)

Muscle Rub Ultra

Section 55105-1 (55105-1)

Topical analgesic

Topical analgesic

Topical analgesic

Directions
  • Use only as directed
  • 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:  ask a doctor

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Questions?

call 1-800-883-0085, weekdays, 9AM -5PM PST

Other Information (Other information)
  • Store at 20 ° to 25 ° C (68 ° to 77 °F)

Active Ingredients

                       

Camphor 4%

Menthol 10%

Methyl Salicylate 30%



Inactive Ingredients

carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

redness over the affected area

Keep Out of Reach of Children to Avoid Accidental Ingestion. (Keep out of reach of children to avoid accidental ingestion.)

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


Advanced Ingredient Data


Raw Label Data

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