Healthwise 2x Medicated Pain Relief Cream Roll-on

Healthwise 2x Medicated Pain Relief Cream Roll-on
SPL v1
SPL
SPL Set ID 33dae8a8-4197-f276-e063-6294a90aea83
Route
TOPICAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.2 g) Menthol (0.1 g)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Maltodextrin Alpha-tocopherol Acetate Cetearyl Alcohol Aminomethylpropanol Propylene Glycol Phenoxyethanol Ethylhexylglycerin Water Capsaicin Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Potassium Cetyl Phosphate

Identifiers & Packaging

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

Description

HealthWise 2X Medicated Pain Relief Cream Roll-on

Purpose

Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic

Topical analgesic

Description

HealthWise 2X Medicated Pain Relief Cream Roll-on

Uses

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

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

HealthWise 2X Medicated Pain Relief Cream Roll-on

Warnings

For external use only

Directions

adults and children 2 years and older:

  • apply to affected area not more than 3 to 4 times daily.

children under 2 years of age: do not use, consult a doctor

Do Not Use

On wounds of damaged skin

Active Ingredient

Menthol 10%

Methyl Salicylate 20%

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, arnica montana flower extract, capsaicin, cetearyl alcohol, ethylhexylglycerin, maltodextrin, phenoxyethanol, potassium cetyl phosphate, propylene glycol, tocopheryl acetate, water

Principal Display Panel

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this carton.
  • avoid contact with eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds
Stop Use and Ask A Doctor If
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Flammable■ Keep away from fire or flame

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

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

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

HealthWise 2X Medicated Pain Relief Cream Roll-on

Purpose

Topical analgesic

Topical analgesic

Warnings

For external use only

Directions

adults and children 2 years and older:

  • apply to affected area not more than 3 to 4 times daily.

children under 2 years of age: do not use, consult a doctor

Do Not Use (Do not use)

On wounds of damaged skin

Active Ingredient (Active ingredient)

Menthol 10%

Methyl Salicylate 20%

Inactive Ingredients (Inactive ingredients)

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, arnica montana flower extract, capsaicin, cetearyl alcohol, ethylhexylglycerin, maltodextrin, phenoxyethanol, potassium cetyl phosphate, propylene glycol, tocopheryl acetate, water

Principal Display Panel

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this carton.
  • avoid contact with eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately
  • do not expose the area treated with product to heat or direct sunlight
  • avoid applying into skin folds
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Flammable■ Keep away from fire or flame

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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


Advanced Ingredient Data


Raw Label Data

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