Quality Choice Ultra Strength Pain Relieving Cream

Quality Choice Ultra Strength Pain Relieving Cream
SPL v2
SPL
SPL Set ID be62b6ea-09ac-0d4b-e053-2a95a90ada65
Route
TOPICAL
Published
Effective Date 2021-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (40 mg) Menthol (100 mg) Salicylic Acid (300 mg)
Inactive Ingredients
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Glyceryl Monostearate Cetyl Alcohol Cetostearyl Alcohol Polyoxyl 100 Stearate Polysorbate 60 Water Methylparaben Stearic Acid Trolamine Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Camphor 4% Menthol 10% Methyl salicylate 30%

Purpose

Camphor - Topical analgesic Menthol - Topical analgesic Methyl salicylate - Topical analgesic


Medication Information

Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Description

Camphor 4% Menthol 10% Methyl salicylate 30%

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises
Warnings

For external use only

Directions
  • adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age; consult a physician
Do Not Use
  • on wounds or damaged skin
  • with a healing pad
  • on a child under 12 years of age with arthritis-like conditions
Active Ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Other Information
  • Store at 20-25 C (68-77F)
  • do not use if tube seal under cap is broken
Inactive Ingredients

carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

Principal Display Panel

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
  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

redness over the affected area


Structured Label Content

Uses

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

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

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Warnings

For external use only

Directions
  • adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age; consult a physician
Do Not Use (Do not Use)
  • on wounds or damaged skin
  • with a healing pad
  • on a child under 12 years of age with arthritis-like conditions
Active Ingredient (Active ingredient)

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Other Information
  • Store at 20-25 C (68-77F)
  • do not use if tube seal under cap is broken
Inactive Ingredients

carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

Principal Display Panel

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)
  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

redness over the affected area


Advanced Ingredient Data


Raw Label Data

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