Assured Extra Strength Cold n hot description, usages, side effects, indications, overdosage, supplying and lots more!

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Assured Extra Strength Cold n hot

Greenbrier International, Inc.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient                                                           Purpose

Menthol 5%.....................................................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.

Inactive ingredients aloe vera, aluminum hydroxide, disodium EDTA, gelatin, kaolin, methacrylic acid copolymer, methylparaben, polysorbate 80, sorbitan monooleate, 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 Extra Strength Cold n hot

Assured Extra Strength Cold n hot

Menthol PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-8463
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 750 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
aluminum hydroxide
EDETATE DISODIUM
GELATIN
KAOLIN
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
METHYLPARABEN
polysorbate 80
SORBITAN MONOOLEATE
sorbitol
tartaric acid
titanium dioxide
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 POUCH
2 NDC:33992-8463-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-06-30


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Be sure to consult your doctor before taking any medication!
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