Coralite Small Pain Relief Patch 20 Ct. 90156

Coralite Small Pain Relief Patch 20 Ct. 90156
SPL v10
SPL
SPL Set ID 69aec845-3d4c-d226-e053-2991aa0afd12
Route
TOPICAL
Published
Effective Date 2018-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (1.2 g) Menthol (5.7 g) Salicylic Acid (6.3 g)
Inactive Ingredients
Aluminum Silicate Butylated Hydroxytoluene Glyceryl Rosinate Lanolin Natural Latex Rubber Paraffin Styrene/isoprene/styrene Block Copolymer Polyisobutylene (85000 Mw) Titanium Dioxide Polyisobutylene (800000 Mw) Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-12

Description

Active ingredients Purpose Camphor 1.2%........................................Topical Analgesic Menthol 5.7%..........................................Topical Analgesic Methyl Salicylate 6.3%............................Topical Analgesic


Medication Information

Warnings and Precautions

Warnings

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 over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not 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 Purpose Camphor 1.2%........................................Topical Analgesic Menthol 5.7%..........................................Topical Analgesic Methyl Salicylate 6.3%............................Topical Analgesic

Section 44425-7

Other information

  • avoid storing product in direct sunlight
  • protect from excessive moisture
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or conduct a Poision Control Center right away

Section 50566-9

Stop use and ask a doctor if

  • redness is present or irritation or rash develops
  • condition 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 other 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 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 53414-9

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

Section 55105-1

Uses

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

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

Active ingredients Purpose

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 over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not 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)

Warnings

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)

Other information

  • avoid storing product in direct sunlight
  • protect from excessive moisture
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or conduct a Poision Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • redness is present or irritation or rash develops
  • condition 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 other 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 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 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

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

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

Active ingredients Purpose

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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