theracare pain relieving muscle vanishing scent rub

theracare pain relieving muscle vanishing scent rub
SPL v4
SPL
SPL Set ID d166aa21-479b-6265-e053-2995a90aca53
Route
topical
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (25 mg)
Inactive Ingredients
butylated hydroxytoluene edetate disodium benzyl alcohol camphor (natural) carbomer 940 dmdm hydantoin isoceteth-20 isopropyl alcohol polyoxyl 40 hydrogenated castor oil sodium hydroxide water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-11-01 Until 2026-03-31

Purpose

Topical analgesic

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

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 physician
Other Information

store at 20° to 25°C (68° to 77°F)

  • Do not use if tube seal under cap is broken
Inactive Ingredients

benzyl alcohol, butylated hydroxtoluene, camphor, carbomer, DMDM hydantoin, edetate disodium, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Description

Drug Facts

Questions?

call 866-326-1313 (toll-free)

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

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

Menthol 2.5%

When Using This Product
  • use only as directed
  • 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
Principal Display Panel 57 G Tube Carton


Structured Label Content

Warnings

For external use only.

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

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 physician
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)

benzyl alcohol, butylated hydroxtoluene, camphor, carbomer, DMDM hydantoin, edetate disodium, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, sodium hydroxide, water

Questions?

call 866-326-1313 (toll-free)

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

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
Active Ingredient (Active ingredient)

Menthol 2.5%

When Using This Product (When using this product)
  • use only as directed
  • 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
Principal Display Panel 57 G Tube Carton (PRINCIPAL DISPLAY PANEL - 57 g Tube Carton)


Advanced Ingredient Data


Raw Label Data

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