Medrox Patch

Medrox Patch
SPL v1
SPL
SPL Set ID 1cf5a566-2d36-4e38-bc1a-09e46d88a3b8
Route
TOPICAL
Published
Effective Date 2013-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g) Capsaicin (0.0375 g)
Inactive Ingredients
Water Glycerin Polysorbate 80 Aloe Vera Leaf Edetate Disodium Diazolidinyl Urea Methylparaben Iodopropynyl Butylcarbamate Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-06-13

Description

Menthol                     5.00% Capsaicin                  0.0375%

Purpose

Analgesic/Counterirritant External Analgesic


Medication Information

Purpose

Analgesic/Counterirritant

External Analgesic

Description

Menthol                     5.00% Capsaicin                  0.0375%

Uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Warnings



  • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Consult physician for  children under 12.
  • Do not use if you are allergic to Menthol
  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days
  • Or rash, itching or excessive skin irritation occurs.

Directions
  • Adults and children 12 years and over apply to affected area: change patch 1 to 2 times daily
  • Children under 12 years, consult physician before use
  • How to apply:
  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches





Other Ingredients



Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodiumm Salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

Active Ingredients



Menthol                     5.00%

Capsaicin                  0.0375%

Medrox Patch 5 Patches



Keep Out of Reach of Children



Structured Label Content

Uses (USES)

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Purpose (PURPOSE)

Analgesic/Counterirritant

External Analgesic

Warnings (WARNINGS)



  • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Consult physician for  children under 12.
  • Do not use if you are allergic to Menthol
  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days
  • Or rash, itching or excessive skin irritation occurs.

Directions (DIRECTIONS)
  • Adults and children 12 years and over apply to affected area: change patch 1 to 2 times daily
  • Children under 12 years, consult physician before use
  • How to apply:
  • Clean and dry affected area
  • Cut open pouch and remove patch
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches





Other Ingredients (OTHER INGREDIENTS)



Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodiumm Salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

Active Ingredients (ACTIVE INGREDIENTS)



Menthol                     5.00%

Capsaicin                  0.0375%

Medrox Patch 5 Patches (MEDROX Patch 5 Patches)



Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)



Advanced Ingredient Data


Raw Label Data

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