Cvs Health Pain-relieving Patch

Cvs Health Pain-relieving Patch
SPL v4
SPL
SPL Set ID 1f90899c-eeca-2362-e063-6294a90aa0da
Route
TOPICAL
Published
Effective Date 2024-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g) Camphor (synthetic) (3.1 g) Menthol (6 g)
Inactive Ingredients
Hydrogenated Polydecene Type I Styrene/acrylamide Copolymer (mw 500000) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Liquid Petroleum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

Camphor 3.1% Menthol 6.0% Methyl Salicylate 10.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl Salicylate 10.0%

Uses

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

Section 51945-4

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before

use.

Directions



Adults and children 12 years of age and over: ■ Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: ■ Consult a physician.

Do Not Use

Do not use■More than one patch on your body at a time■ On wounds or damaged skin■ With a heating

pad ■If you are allergic to any 1ngred1ents of this product

Other Information

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

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl Salicylate 10.0%

Inactive Ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Questions Or Comments

Call 1-866-326-1313

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

(1-800-222-1222) right away

Stop Use and Consult A Doctor If

■Rash, itching or excessive skin irritation develops

■ Condition worsens

■Symptoms last more than 7 days or clear up and occur again within a few days.


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before

use.

Directions



Adults and children 12 years of age and over: ■ Clean and dry affected area, free of lotions, ointments and creams. Remove patch from film, apply to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening. Children under 12 years of age: ■ Consult a physician.

Do Not Use (Do not use)

Do not use■More than one patch on your body at a time■ On wounds or damaged skin■ With a heating

pad ■If you are allergic to any 1ngred1ents of this product

Other Information (Other information)

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

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl Salicylate 10.0%

Inactive Ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Questions Or Comments (Questions or comments)

Call 1-866-326-1313

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

(1-800-222-1222) right away

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

■Rash, itching or excessive skin irritation develops

■ Condition worsens

■Symptoms last more than 7 days or clear up and occur again within a few days.


Advanced Ingredient Data


Raw Label Data

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