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

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
Section 55106-9

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Warnings

For external use only.

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
Do Not Use
  • than otherwise directed
  • on wounds or damaged skin
  • a bandage tightly
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

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

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
Section 55106-9 (55106-9)

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Warnings

For external use only.

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
Do Not Use (Do not use)
  • than otherwise directed
  • on wounds or damaged skin
  • a bandage tightly
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

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:14.280472 · Updated: 2026-03-14T23:08:54.445441