healthwise ultra otc strength pain relief cream

healthwise ultra otc strength pain relief cream
SPL v1
SPL
SPL Set ID 36c3bbf9-a559-4c0d-e063-6394a90a8a1a
Route
topical
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
camphor (natural) (40 mg) menthol, unspecified form (100 mg) salicylic acid (300 mg)
Inactive Ingredients
carbomer interpolymer type a (55000 cps) glyceryl 1-stearate lanolin polysorbate 80 potassium hydroxide edetate disodium anhydrous water stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-01

Description

Drug Facts


Medication Information

Warnings

For external use only.

Active Ingredient

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Directions

Adults and children 2 years of age and older:

  • apply to affected area no more than 3 to 4 times daily

Children under 2 years of age:

  • do not use, ask a doctor
Other Information
  • store at 20°C -25°C(68 to 77°F)
Inactive Ingredients

Inactive ingredients

carbomer, disodium EDTA, glyceryl stearate, lanolin, polysorbate 80, potassium hydroxide, stearic acid, water

Description

Drug Facts

Use

For the temporary relief of minor aches and pains of muscle 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: 800-222-1222.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1
Active ingredients Purpose
Camphor 4% Topical analgesic
Menthol 10% Topical analgesic
Methyl salicylate 30% Topical analgesic
Do Not Use
  • than otherwise directed
  • on wounds or damaged skin
  • a bandage tightly
Questions Or Comments?

1-866-323-1313

Stop Use and Ask A Physician If
  • rash or excessive irritation of the skin develops
  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Principal Display Panel 113 G Tube Carton


Structured Label Content

Warnings

For external use only.

Active Ingredient (55106-9)

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Directions

Adults and children 2 years of age and older:

  • apply to affected area no more than 3 to 4 times daily

Children under 2 years of age:

  • do not use, ask a doctor
Other Information (Other information)
  • store at 20°C -25°C(68 to 77°F)
Inactive Ingredients (Inactive ingredients)

Inactive ingredients

carbomer, disodium EDTA, glyceryl stearate, lanolin, polysorbate 80, potassium hydroxide, stearic acid, water

Use

For the temporary relief of minor aches and pains of muscle 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: 800-222-1222.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Section 55105-1 (55105-1)
Active ingredients Purpose
Camphor 4% Topical analgesic
Menthol 10% Topical analgesic
Methyl salicylate 30% Topical analgesic
Do Not Use (Do not use)
  • than otherwise directed
  • on wounds or damaged skin
  • a bandage tightly
Questions Or Comments? (Questions or comments?)

1-866-323-1313

Stop Use and Ask A Physician If (Stop use and ask a physician if)
  • rash or excessive irritation of the skin develops
  • condition worsens or symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
Principal Display Panel 113 G Tube Carton (PRINCIPAL DISPLAY PANEL - 113 g Tube Carton)


Advanced Ingredient Data


Raw Label Data

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