Coralite Small Menthol Pain Relief Sleeve 1ct 90122 Zdp

Coralite Small Menthol Pain Relief Sleeve 1ct 90122 Zdp
SPL v8
SPL
SPL Set ID ae314478-b8ab-4e90-bd0a-7a882d5c1b2e
Route
TOPICAL
Published
Effective Date 2016-02-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

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 wrist, ankle or elbow 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 immediately.

Section 50566-9

Stop use and ask a doctor if

  • condition worsens, or if 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

Inactive ingredients

carbomber 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 wrist, ankle or elbow 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 immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens, or if 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)

Inactive ingredients

carbomber 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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