Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 16e6be21-7b43-443a-89ec-3bdf0ec0dfc1
Route
TOPICAL
Published
Effective Date 2024-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (31 mg) Capsaicin (0.25 mg) Menthol, Unspecified Form (100 mg) Salicylic Acid (150 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Cetyl Alcohol Cetyl Esters Wax Isocetyl Stearate Carnauba Wax Oleth-3 Phosphate Water Sodium Hydroxide Stearic Acid

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-06

Description

Camphor 3.1% Capsaicin 0.025% Menthol 10% Methyl salicylate 15%

Purpose

Topical analgesic Topical analgesic Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic Topical analgesic Topical analgesic Topical analgesic

Description

Camphor 3.1% Capsaicin 0.025% Menthol 10% Methyl salicylate 15%

Uses
  • Temporarily relieves minor aches and pains of muscles and joints associated with:
  • arthritis
  • strains
  • simple backache
  • bruises
  • sprains
Purposes

Topical analgesic

Topical analgesic

Topical analgesic

Topical analgesic

Warnings

For external use only

  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
Directions
  • use only as directed
  • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult your doctor
  • wash hands after applying
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients in this product
Other Information
  • store between 20-25°C (68-77°F)
Active Ingredients

Camphor 3.1%

Capsaicin 0.025%

Menthol 10%

Methyl salicylate 15%

Inactive Ingredients

carbomer homopolymer, cetyl alcohol, cetyl esters wax, emulsifying wax, oleth-3-phosphate, purified water, sodium hydroxide, stearic acid

Additional Information

DEEP PENETRATING RELIEF

BACK & BODY ACHES

ARTHRITIS & JOINT PAIN

SPRAINS & STRAINS

SORE MUSCLES

STARTS WORKING ON CONTACT

FOR UP TO 8 HOURS OF POWERFUL RELIEF

UP TO 8 HRS

HOW TO USE

Clean and dry affected area

Remove cap

Gently squeeze to dispense cream

Massage cream into skin

Starts to soothe on contact

Do Not Use if tube seal under cap is broken or missing.

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon group of companies or its licensor.

Trademarks are owned by or licensed to the Haleon group of companies.

For most recent product information, visit www.Advil.com

Made in Canada

Questions Or Comments?

call toll-free 1-800-88-ADVIL

Principal Display Panel

NEW HALEON

DOES NOT CONTAIN THE SAME ACTIVE INGREDIENT AS ADVIL

Advil

TARGETED

RELIEF

PAIN RELIEVING CREAM

4 POWERFUL PAIN FIGHTING INGREDIENTS

Arthritis & Joint Pain

Sprains & Strains

Back & Body aches

Sore Muscles

FOR EXTERNAL USE ONLY

NET WT. 65 g (2.3 oz)

206239 Front

When Using This Product
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens or if symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash, itching or skin irritation develops
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:
  • arthritis
  • strains
  • simple backache
  • bruises
  • sprains
Purposes

Topical analgesic

Topical analgesic

Topical analgesic

Topical analgesic

Warnings

For external use only

  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
Directions
  • use only as directed
  • adults and children 12 years and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult your doctor
  • wash hands after applying
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients in this product
Other Information (Other information)
  • store between 20-25°C (68-77°F)
Active Ingredients (Active ingredients)

Camphor 3.1%

Capsaicin 0.025%

Menthol 10%

Methyl salicylate 15%

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer, cetyl alcohol, cetyl esters wax, emulsifying wax, oleth-3-phosphate, purified water, sodium hydroxide, stearic acid

Additional Information (Additional information)

DEEP PENETRATING RELIEF

BACK & BODY ACHES

ARTHRITIS & JOINT PAIN

SPRAINS & STRAINS

SORE MUSCLES

STARTS WORKING ON CONTACT

FOR UP TO 8 HOURS OF POWERFUL RELIEF

UP TO 8 HRS

HOW TO USE

Clean and dry affected area

Remove cap

Gently squeeze to dispense cream

Massage cream into skin

Starts to soothe on contact

Do Not Use if tube seal under cap is broken or missing.

Distributed by: Haleon, Warren, NJ 07059

©2023 Haleon group of companies or its licensor.

Trademarks are owned by or licensed to the Haleon group of companies.

For most recent product information, visit www.Advil.com

Made in Canada

Questions Or Comments? (Questions or comments?)

call toll-free 1-800-88-ADVIL

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW HALEON

DOES NOT CONTAIN THE SAME ACTIVE INGREDIENT AS ADVIL

Advil

TARGETED

RELIEF

PAIN RELIEVING CREAM

4 POWERFUL PAIN FIGHTING INGREDIENTS

Arthritis & Joint Pain

Sprains & Strains

Back & Body aches

Sore Muscles

FOR EXTERNAL USE ONLY

NET WT. 65 g (2.3 oz)

206239 Front

When Using This Product (When using this product)
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or if symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days
  • rash, itching or skin irritation develops
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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