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

Purpose

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

Description

Camphor 4% Menthol 10% Methyl salicylate 30%


Medication Information

Warnings

For external use only

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

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
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

Description

Camphor 4% Menthol 10% Methyl salicylate 30%

Principal Display Panel

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%

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

Warnings

For external use only

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

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
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

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%

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

All Sections (JSON)