Coralite Large Menthol Pain Relief Sleeve 1ct 90121 Zdp

Coralite Large Menthol Pain Relief Sleeve 1ct 90121 Zdp
SPL v8
SPL
SPL Set ID aa5873bd-af64-41cc-8f16-7714c56bca96
Route
TOPICAL
Published
Effective Date 2016-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (336 mg)
Inactive Ingredients
Trolamine Carbomer 940 Alcohol Glycerin Propylene Glycol Water Ethylparaben

Identifiers & Packaging

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

Description

Active ingredient                                                                      Purpose Menthol 16.0%..................................................Topical Analgesic Patch


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • adults and children 12 years of age and older:
  • open pouch and remove sleeve
  • remove plastic insert and discard
  • pull sleeve onto knee, large ankles or elbows until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this.
  • apply one sleeve to affected area no more than 3 times daily
  • do not wear sleeve for more than 8 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 ingredient                                                                      Purpose Menthol 16.0%..................................................Topical Analgesic Patch

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
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 or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or irritation or rash develops
Section 50567-7

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly over sleeve or use with a heating pad
  • 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
  • on a child under 12 years of age with arthritis-like-conditions
Section 51727-6

Inative ingredients

carbomer 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

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

Active ingredient                                                                      Purpose

Menthol 16.0%..................................................Topical Analgesic Patch


Structured Label Content

Indications and Usage (34067-9)

Directions

  • adults and children 12 years of age and older:
  • open pouch and remove sleeve
  • remove plastic insert and discard
  • pull sleeve onto knee, large ankles or elbows until the colored (medicated) section of the sleeve is positioned directly over the affected area. Sleeve should feel snug, but not tight. Note: the drawings should help you understand how to do this.
  • apply one sleeve to affected area no more than 3 times daily
  • do not wear sleeve for more than 8 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

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
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 or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or irritation or rash develops
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 over sleeve or use with a heating pad
  • 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
  • on a child under 12 years of age with arthritis-like-conditions
Section 51727-6 (51727-6)

Inative ingredients

carbomer 940, ethanol, ethylparaben, glycerol, propylene glycol, purified water, trolamine

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

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

Active ingredient                                                                      Purpose

Menthol 16.0%..................................................Topical Analgesic Patch


Advanced Ingredient Data


Raw Label Data

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