Coralite Pain Relief Extra Strength Hot Patch 2ct 90152 (90152, 2021)

Coralite Pain Relief Extra Strength Hot Patch 2ct 90152 (90152, 2021)
SPL v5
SPL
SPL Set ID 78eb133d-01bb-6466-e053-2991aa0accc0
Route
TOPICAL
Published
Effective Date 2018-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (30 mg) Capsaicin (0.83 mg)
Inactive Ingredients
Titanium Dioxide Glycerin Alcohol Tartaric Acid Methylparaben Polysorbate 80 Propylparaben Water Dihydroxyaluminum Aminoacetate Anhydrous Sodium Polyacrylate (2500000 Mw) Sorbitan Monooleate Kaolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-23

Description

Drug Facts Active ingredient Purpose Capsicum extract 0.17 mg as Capsaicin........Topical analgesic Menthol 30 mg....................................................Topical analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only

Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

Indications and Usage

Directions

  • adults and children 18 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • removed patch from the skin after 8 hours application
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made In China

Description

Drug Facts Active ingredient Purpose Capsicum extract 0.17 mg as Capsaicin........Topical analgesic Menthol 30 mg....................................................Topical analgesic

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present or irritation or rash develops
  • a severe burning sensation occurs
Section 50567-7

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
Section 50570-1

Do not use

  • on wounds or damaged skin
  • with a heating pad
Section 51727-6

Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Section 51945-4

Section 53413-1

Questions or comments?

Call 1-800-814-8028 monday-Friday 9AM-5PM (PST)

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

temporarily relieves minor pain of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Section 55106-9

Drug Facts

Active ingredient Purpose

Capsicum extract 0.17 mg as Capsaicin........Topical analgesic

Menthol 30 mg....................................................Topical analgesic


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children 18 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • removed patch from the skin after 8 hours application
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed By: UNITED EXCHANGE CORPORATION

Cypress, CA 90630 USA | 1-888-645-8204

Made In China

Warnings and Precautions (34071-1)

Warnings

For external use only

Allergy alert: Do not use if you are allergic to capsicum, chili peppers, or any ingredients in this product.

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present or irritation or rash develops
  • a severe burning sensation occurs
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower
Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • with a heating pad
Section 51727-6 (51727-6)

Inactive ingredients alcohol, aluminum glycinate, glycerin, kalin, methylparaben, polysorbate 80, propylparaben, purified water, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-814-8028 monday-Friday 9AM-5PM (PST)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

temporarily relieves minor pain of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises
Section 55106-9 (55106-9)

Drug Facts

Active ingredient Purpose

Capsicum extract 0.17 mg as Capsaicin........Topical analgesic

Menthol 30 mg....................................................Topical analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)