Best Choice Pain Reliever Cream

Best Choice Pain Reliever Cream
SPL v1
SPL
SPL Set ID 130665d6-3de8-cb91-e063-6294a90a2083
Route
TOPICAL
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g) Salicylic Acid (15 g)
Inactive Ingredients
Polysorbate 80 Trolamine Propylparaben Carbomer 940 Cetyl Alcohol Glyceryl Monostearate Methylparaben Water Stearic Acid Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-06

Description

Menthol 10%


Medication Information

Indications and Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Description

Menthol 10%

Section 55105-1

Topical Analgesic

Warnings

For external use only

Do not use:

  • On wounds or damaged, broken, (open) or irritated skin
  • With a heating pad

Packaging

Directions
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Distributed By

Proudly Distributed By

Associated Wholesale Grocers, Inc.

Kansas City, Kansas

66106

Active Ingredient

Menthol 10%

Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ?Call 1-800-883-0085

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Ask A Doctor Before Use

If you are pregant or breast feeding.

When Using This Product

Avoid contact with eyes or mucous membrane.

Do not bandage tightly

Stop Use and Ask A Doctor
  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Section 55105-1 (55105-1)

Topical Analgesic

Warnings

For external use only

Do not use:

  • On wounds or damaged, broken, (open) or irritated skin
  • With a heating pad

Packaging

Directions
  • Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.

Children under 12 years of age. consult a doctor

  • Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Distributed By

Proudly Distributed By

Associated Wholesale Grocers, Inc.

Kansas City, Kansas

66106

Active Ingredient

Menthol 10%

Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)

Questions ?Call 1-800-883-0085

Inactive Ingredients

Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine

Ask A Doctor Before Use (Ask a doctor before use)

If you are pregant or breast feeding.

When Using This Product (When using this product)

Avoid contact with eyes or mucous membrane.

Do not bandage tightly

Stop Use and Ask A Doctor (Stop Use and ask a doctor)
  • Conditions worsens or does not improve within 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation develops

A temporary burning sensation may occur upon application, but generally disappears in a few days

Keep Out of the Reach of Children (Keep out of the reach of Children)

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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