Cold and Hot Pain Relief Sleeve description, usages, side effects, indications, overdosage, supplying and lots more!

Cold and Hot Pain Relief Sleeve

Kareway Product, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin

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
  • irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years

  • Clean and dry affected area.
  • Cut open pouch and remove Sleeve.
  • Remove the clear plastic insert.
  • Pull Sleeve onto knee, large ankle or elbow.
  • Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.
  • Pull Sleeve over itself to make medicine touch directly on your skin.
  • Apply one Sleeve to affected area.
  • Repeat as necessary , but no more than 4 times a day.
  • Sleeve should fit snug, but not tight.
Children 12 years or younger:

Inactive ingredients

Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water

Package label

Package label

Cold and Hot Pain Relief Sleeve

Menthol PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67510-0085
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 400 mg

Inactive Ingredients

Ingredient Name Strength
GLYCERIN
ISOPROPYL ALCOHOL
polysorbate 80
METHYLPARABEN
PROPYLPARABEN
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 POUCH
2 NDC:67510-0085-4 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-04-19


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Be sure to consult your doctor before taking any medication!
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