ASSURED PAIN RELIEF HOT PATCH description, usages, side effects, indications, overdosage, supplying and lots more!

ASSURED PAIN RELIEF HOT PATCH

Greenbrier International, 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

Active ingredient

Active ingredients                                                                         Purpose

Menthol 30mg...............................................................................Topical Analgesic

Capsicum Extract (capsaicin) 8.3mg...............................................Topical Analgesic

Purpose

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

For external use only

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

When using this product

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

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops

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

Uses

Directions

  • Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: do not use, consult a doctor
  • For easy application: partially peel back protective film and apply exposed patch to site of pain
  • Carefully remove remaining film while pressing patch to skin for secure adhesion
  • Store unused patch in pouch.  Reseal pouch after opening

Inactive ingredients

aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monostearate, sorbitol solution, tartaric acid, titanium dioxide, tocopheryl acetate (vitamin E), water

Distributed by:

Greenbrier International, Inc.

500 Volvo Parkway

Chesapeake, VA 23320

Made in Korea

ASSURED PAIN RELIEF HOT PATCH

MENTHOL, CAPSICUM OLEORESIN PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-1889
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 30 mg
capsaicin CAPSAICIN 8.3 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
aluminum hydroxide
EDETATE DISODIUM
GELATIN
KAOLIN
METHYLPARABEN
polysorbate 80
sorbitol
tartaric acid
titanium dioxide
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 PACKET
2 NDC:33992-1889-2 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-03-31


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Be sure to consult your doctor before taking any medication!
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