Coralite Hot Capsaicin Patch 1ct, 2ct (nb Salonpas) 90132a And 90198

Coralite Hot Capsaicin Patch 1ct, 2ct (nb Salonpas) 90132a And 90198
SPL v12
SPL
SPL Set ID a0b89c7e-80bc-43c4-840c-5fd567f60b21
Route
TOPICAL
Published
Effective Date 2024-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (249 mg)
Inactive Ingredients
Zinc Oxide Styrene/isoprene/styrene Block Copolymer Titanium Dioxide Lanolin Butylated Hydroxytoluene Diphenhydramine Hydrochloride Glyceryl Rosinate Natural Latex Rubber Petrolatum Polyisobutylene (85000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-10

Description

Active ingredient                                                           Purpose Capsicum Extract Capsaicin 0.025%..............................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
  • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
Indications and Usage

Directions

  • adults and children 12 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily
  • do not wear patch more than 8 hours
  • children under 12 years of age: consult a doctor
Dosage and Administration

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

Made in China

Description

Active ingredient                                                           Purpose Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic

Section 44425-7

Other information

  • 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:

  • do not use otherwise than 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

butylated hydroxytoluene, diphenhydramine, hydrochloride, glyceryl, rosinate, lanolin, natural rubber, petrolatum, polyisobutylene (85,000 MW), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Section 51945-4

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
Section 55106-9

Active ingredient                                                           Purpose

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children 12 years of age and older:
  • clean and dry affected area
  • remove patch from film
  • apply to affected area no more than 3 to 4 times daily
  • do not wear patch more than 8 hours
  • children under 12 years of age: consult a doctor
Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

5836 Corporate Ave.

Cypress, CA 90630 USA

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
  • if prone to allergic reaction from aspirin or salicylates, consult a doctor before use
Section 44425-7 (44425-7)

Other information

  • 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:

  • do not use otherwise than 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

butylated hydroxytoluene, diphenhydramine, hydrochloride, glyceryl, rosinate, lanolin, natural rubber, petrolatum, polyisobutylene (85,000 MW), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

For temporary relief of minor aches and pains of muscles & joints associated with:

  • Simple Backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
Section 55106-9 (55106-9)

Active ingredient                                                           Purpose

Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic


Advanced Ingredient Data


Raw Label Data

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