debbie's down & dirty deep tissue joint and muscle cream

debbie's down & dirty deep tissue joint and muscle cream
SPL v2
SPL
SPL Set ID 531fe834-53e3-305f-e054-00144ff88e88
Route
topical
Published
Effective Date 2017-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (100 mg)
Inactive Ingredients
helianthus annuus flowering top methyl salicylate dimethyl sulfone peg-100 stearate phenoxyethanol willow bark trolamine xanthan gum water arnica montana flower indian frankincense bromelains butylene glycol carboxypolymethylene cetyl alcohol ethylhexylglycerin eucalyptus oil glyceryl monostearate glycyrrhiza glabra

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-06-28

Purpose

Topical Analgesic

Description

Menthol 10%


Medication Information

Warnings

For external use only

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

Purpose

Topical Analgesic

Directions

Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Carbomer, Cetyl lcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Salic Nigra (Willow Bark) Extract, Triethanolamine, Xanthan Gum.

Description

Menthol 10%

Do Not Apply

to wounds or damaged skin.

Package Labeling:

Active Ingredients

Menthol 10%

When Using This Product
  • avoid contact with the eyes.
  • do not bandage.
Ask A Physician Before Use If

you have redness over the affected area.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Physician 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.

Structured Label Content

Warnings

For external use only

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple back ache • arthritis • sprains • strains • and bruises

Purpose

Topical Analgesic

Directions

Use only as directed Adults and children 12 years of age and older: apply generously to affected area. Massage into painful area until thoroughly absorbed into skin. Children under 12 years of age: consult a physician.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Carbomer, Cetyl lcohol, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Methyl Salicylate, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Salic Nigra (Willow Bark) Extract, Triethanolamine, Xanthan Gum.

Do Not Apply (Do not apply)

to wounds or damaged skin.

Package Labeling: (Package labeling:)

Active Ingredients

Menthol 10%

When Using This Product (When using this product)
  • avoid contact with the eyes.
  • do not bandage.
Ask A Physician Before Use If (Ask a physician before use if)

you have redness over the affected area.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Physician If (Stop use and ask a physician 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.

Advanced Ingredient Data


Raw Label Data

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