Signature Care Medicated Cold & Hot Patch

Signature Care Medicated Cold & Hot Patch
SPL v4
SPL
SPL Set ID 0335f1b3-5c8a-67b8-e063-6294a90a9847
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Phenoxyethanol Carboxymethylcellulose Sodium Dihydroxyaluminum Aminoacetate Kaolin Polyacrylic Acid (8000 Mw) Propylene Glycol Sodium Polyacrylate (8000 Mw) Water Glycerin Tartaric Acid Titanium Dioxide Mineral Oil Petrolatum Ethylhexylglycerin Polysorbate 80 Povidone Iodopropynyl Butylcarbamate

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Use

For temporary relief of minor muscle and joint pain

Warning

For external use only

Questions

Toll Free 1-866-723-3929

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch at a time. Repeat as necessary, but no more than 3 times daily. Discard patch after single use.

Reseal pouch after opening. Children under 12 years of age: consult a physician.

Active Ingredient

Menthol 5%

Other Information

Store at room temperature, no to exceed 86F (30C)

Inactive Ingredients

Inactive ingredients

Carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product

■Use only as directed

■Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■Don't apply to wounds or damaged skin

■Do not use at the same time as other topical analgesics.

If Pregnant Or Breastfeeding

ask a health professional before use

Keep Out of Reach of Children

Keep out of reach of children. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Stop Use and Consult A Doctor If

■ Condition worsens

■Redness is present

■Irritation develops

■Symptoms persist

for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Signature Care Medicated Cold & Hot Patch


Structured Label Content

Use

For temporary relief of minor muscle and joint pain

Purpose

Topical analgesic

Warning

For external use only

Questions

Toll Free 1-866-723-3929

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Use one patch at a time. Repeat as necessary, but no more than 3 times daily. Discard patch after single use.

Reseal pouch after opening. Children under 12 years of age: consult a physician.

Active Ingredient

Menthol 5%

Other Information (Other information)

Store at room temperature, no to exceed 86F (30C)

Inactive Ingredients

Inactive ingredients

Carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

When Using This Product (When using this product)

■Use only as directed

■Rare cases of serious burns have been reported with products of this type

■Don't bandage tightly or use with heating pad

■ Avoid contact with eyes and mucous membranes

■Don't apply to wounds or damaged skin

■Do not use at the same time as other topical analgesics.

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)

Keep out of reach of children. Do not use on infants. 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)

■ Condition worsens

■Redness is present

■Irritation develops

■Symptoms persist

for more than 7 days or clear up and occur again within a few days

■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Signature Care Medicated Cold & Hot Patch


Advanced Ingredient Data


Raw Label Data

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