Coralite Muscle & Joint Pain Relief Patch 2ct (90155)

Coralite Muscle & Joint Pain Relief Patch 2ct (90155)
SPL v9
SPL
SPL Set ID 78edeeb8-3e3c-64bb-e053-2a91aa0a7bbc
Route
TOPICAL
Published
Effective Date 2018-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (12 mg) Menthol (57 mg) Salicylic Acid (63 mg)
Inactive Ingredients
Aluminum Silicate Butylated Hydroxytoluene Glyceryl Rosinate Lanolin Natural Latex Rubber Paraffin Polyisobutylene (800000 Mw) Polyisobutylene (85000 Mw) Styrene/isoprene/styrene Block Copolymer (styrene/isoprene 15/85) Titanium Dioxide Zinc Oxide

Identifiers & Packaging

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

Description

Active Ingredients Purposes Camphor 1.2%...................Topical analgesic Menthol 5.7%.....................Topical analgesic Methyl salicylate 6.3%.......Topical analgesic


Medication Information

Warnings and Precautions

For external use only

Allergy alert: 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 for more than 4 hours
  • children under 12 years of age: consult a doctor
Dosage and Administration

Distributed By:

UNITED EXCHANGE CORP.

Cypress, CA. 90630 USA

Made in China

Description

Active Ingredients Purposes Camphor 1.2%...................Topical analgesic Menthol 5.7%.....................Topical analgesic Methyl salicylate 6.3%.......Topical analgesic

Section 44425-7
  • store at room temperature 20-25°C (68-77ºF)
  • 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

  • redness is present or irritation or rash develops
  • conditioin worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
Section 50567-7

When using this product

  • do not use otherwise than as directed
  • avoid contact with 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 50569-3

Ask a doctor before use if you have redness over the affected area.

Section 50570-1

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6

Inactive ingredients

aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin, polyisobutylene (800000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Section 51945-4

Section 53413-1

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 the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthritis
  • strains
  • bruises
Section 55106-9

Active Ingredients Purposes

Camphor 1.2%...................Topical analgesic

Menthol 5.7%.....................Topical analgesic

Methyl salicylate 6.3%.......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 for more than 4 hours
  • children under 12 years of age: consult a doctor
Dosage and Administration (34068-7)

Distributed By:

UNITED EXCHANGE CORP.

Cypress, CA. 90630 USA

Made in China

Warnings and Precautions (34071-1)

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Section 44425-7 (44425-7)
  • store at room temperature 20-25°C (68-77ºF)
  • 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

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

When using this product

  • do not use otherwise than as directed
  • avoid contact with 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 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6 (51727-6)

Inactive ingredients

aluminum silicate, butylated hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin, polyisobutylene (800000 mw), polyisobutylene (85000 mw), styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

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 the minor aches and pains of muscles and joints associated with:
  • sprains
  • simple backache
  • arthritis
  • strains
  • bruises
Section 55106-9 (55106-9)

Active Ingredients Purposes

Camphor 1.2%...................Topical analgesic

Menthol 5.7%.....................Topical analgesic

Methyl salicylate 6.3%.......Topical analgesic


Advanced Ingredient Data


Raw Label Data

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