Rite Aid Hot And Cold Back Patch

Rite Aid Hot And Cold Back Patch
SPL v3
SPL
SPL Set ID efa51d1f-ed09-680c-e053-2a95a90af1b2
Route
TOPICAL
Published
Effective Date 2023-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Polyethylene Glycol 400 Tartaric Acid Povidone Carboxymethylcellulose Sodium, Unspecified Form Sodium Polyacrylate (8000 Mw) Mineral Oil Water Polyacrylic Acid (8000 Mw) 3-iodo-2-propynol Phenoxyethanol Dihydroxyaluminum Aminoacetate Glycerin Titanium Dioxide Kaolin Petrolatum Polysorbate 80 Iodopropynyl Butylcarbamate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

Menthol 5%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Menthol 5%

Use

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

Warnings

For external use only

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one patch up to 8 hours. 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, not to exceed 86'F (30'C).

Inactive Ingredient

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 Breast Feeding

ask a health professional before use.

Rite Aid Hot and Cold Back Patch

Stop Use and Consult A Doctor If

o condition worsens

o redness is present

o irritation develops

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

o you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Keep Out of Reach of Children and Pets

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


Structured Label Content

Use

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

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and over: Carefully remove backing from patch. Apply sticky side of patch to affected area. Wear one patch up to 8 hours. 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, not to exceed 86'F (30'C).

Inactive Ingredient

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 Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Rite Aid Hot and Cold Back Patch

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

o condition worsens

o redness is present

o irritation develops

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

o you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

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


Advanced Ingredient Data


Raw Label Data

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