Theracare Muscle & Join Pain Relieving Cream

Theracare Muscle & Join Pain Relieving Cream
SPL v4
SPL
SPL Set ID 18f9829e-c5f9-4253-e063-6394a90a70c6
Route
TOPICAL
Published
Effective Date 2024-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Butylated Hydroxytoluene Phenoxyethanol Carbomer 940 Cetyl Alcohol Peg-100 Stearate Glyceryl Monostearate Sodium Benzoate Trolamine Cetostearyl Alcohol Sodium Borate Stearic Acid Water Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50569-3

Ask a doctor before use if you have redness over the affected area

Section 55105-1
Active ingredients Purpose
Menthol 10% Topical analgesic
Methyl salicylate 15% Topical analgesic
Section 55106-9

Menthol 10%

Methyl salicylate 15%

Warnings

For external use only.

Directions

  • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician.
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Other Information

store at 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive Ingredients

borax, butylated hydroxy1oluene, carbopol 940, cetostearyl alcohol, cetyl alcohol, glycerol monostearate, peg 100 stearate, phenoxyethanol, sodium benzoate, stearic acid, trolamine, tween 60, water

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • excessive skin irritation occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Theracare Muscle & Joint Pain Relief Cream


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area

Section 55105-1 (55105-1)
Active ingredients Purpose
Menthol 10% Topical analgesic
Methyl salicylate 15% Topical analgesic
Section 55106-9 (55106-9)

Menthol 10%

Methyl salicylate 15%

Warnings

For external use only.

Directions

  • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician.
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
Other Information (Other information)

store at 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive Ingredients (Inactive ingredients)

borax, butylated hydroxy1oluene, carbopol 940, cetostearyl alcohol, cetyl alcohol, glycerol monostearate, peg 100 stearate, phenoxyethanol, sodium benzoate, stearic acid, trolamine, tween 60, water

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)
  • excessive skin irritation occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Theracare Muscle & Joint Pain Relief Cream (TheraCare Muscle & Joint Pain Relief Cream)


Advanced Ingredient Data


Raw Label Data

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