Pain Relieving Patches

Pain Relieving Patches
SPL v3
SPL
SPL Set ID f9ecfff2-3367-415f-bf68-1a8b7dfe84b8
Route
TOPICAL
Published
Effective Date 2016-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (3.1 g) Menthol (6 g) Salicylic Acid (10 g)
Inactive Ingredients
Hydrogenated Poly(c6-14 Olefin; 2 Cst) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum Styrene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-01

Description

Active Ingredient Purpose Camphor 3.1% Topical Analgesic Menthol 6.0% Topical Analgesic Methyl Salicylate 10.0% Topical Analgesic

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Active Ingredient Purpose Camphor 3.1% Topical Analgesic Menthol 6.0% Topical Analgesic Methyl Salicylate 10.0% Topical Analgesic

Warnings

For External Use Only

Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.

Do Not Use
  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients in this product.
Storage and Care

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Active Ingredient

Active Ingredient Purpose
Camphor 3.1% Topical Analgesic
Menthol 6.0% Topical Analgesic
Methyl Salicylate 10.0% Topical Analgesic

Indications & Usage

For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.

Pain Relieving Path

DIST. BY

Walgreens Co.

200 Wilmot Rd

. Deerfield, IL 60015

www.walgreens.com

TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313

Dosage & Administration

Adults and children over 12 years:

Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.

Do not use for more than 8 hours.

Discard patch after use.

Reseal pouch after opening.

Children under 12 years of age, consult a physician.

When Using This Product:

■ Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Do not use at the same time as other topical analgesics ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.

If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out of Reach of Children

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

Stop Use and Consult A Doctor
  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • If symptoms last more than 7 days or clear up and occur again in a few days.
Inactive Ingredienthydrogenated Poly, Pentaerythrityl Tetra Di T Butyl Hydroxyhydrocinnamate, Petroleum, Styrene/isoprene Copolymer


Structured Label Content

Purpose (PURPOSE)

Topical Analgesic

Warnings (WARNINGS)

For External Use Only

Allergy Alert:If prone to allergic reactions from aspirine or salicytates, consult a doctor before use.

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.
Storage and Care

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Active Ingredient (ACTIVE INGREDIENT)

Active Ingredient Purpose
Camphor 3.1% Topical Analgesic
Menthol 6.0% Topical Analgesic
Methyl Salicylate 10.0% Topical Analgesic

Indications & Usage (INDICATIONS & USAGE)

For temporary relief of minor aches and pains of muscles and joins: arthritis, simple backache, muscle strains, muscle sprains and bruises.

Pain Relieving Path

DIST. BY

Walgreens Co.

200 Wilmot Rd

. Deerfield, IL 60015

www.walgreens.com

TOLL-FREE CUSTOMER CARE HELP LINE Mon–Fri, 8:30 am–4:30 pm CST 866-326-1313

Dosage & Administration (DOSAGE & ADMINISTRATION)

Adults and children over 12 years:

Clean and dry affected area. Remove patch from film, apply to affected area not more than 3-4 times a day.

Do not use for more than 8 hours.

Discard patch after use.

Reseal pouch after opening.

Children under 12 years of age, consult a physician.

When Using This Product: (When using this product:)

■ Use only as directed ■ Avoid contact with eyes, mucous membranes or rashes ■ Do not bandage tightly ■ Do not use at the same time as other topical analgesics ■ Dispose of used patch away from children and pets. Used patches still contain the drug product which can produce serious adverse effects if a child or pet chews or ingests the patch.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

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 (800-222-1222) right away.

Stop Use and Consult A Doctor (Stop use and consult a doctor)
  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • If symptoms last more than 7 days or clear up and occur again in a few days.
Inactive Ingredienthydrogenated Poly, Pentaerythrityl Tetra Di T Butyl Hydroxyhydrocinnamate, Petroleum, Styrene/isoprene Copolymer (INACTIVE INGREDIENThydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer)


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