Healthwise 3x Medicated Pain Relief Patch

Healthwise 3x Medicated Pain Relief Patch
SPL v1
SPL
SPL Set ID 164d4d62-00c0-e06d-e063-6294a90abd73
Route
TOPICAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-01

Description

Camphor 3.1% Menthol 6% Methyl Salicylate 10%

Purpose

Topical analgesic Topical analgesic Topical analgesic


Medication Information

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Description

Camphor 3.1% Menthol 6% Methyl Salicylate 10%

Use

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

Active I

Camphor 3.1%

Menthol 6%

Methyl Salicylate 10%

Keep Out

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

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 a 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

■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 ingredients of this product.

Other Information

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

Inactive Ingredients

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

Principal Display Panel

When Using This Product

■Use only as directed and 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.

Stop Use and Ask 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.


Structured Label Content

Use

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

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Active I (Active i)

Camphor 3.1%

Menthol 6%

Methyl Salicylate 10%

Keep Out (Keep out)

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

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 a 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 ingredients of this product.

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

■Use only as directed and 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.

Stop Use and Ask A Doctor If (Stop use and ask 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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)