Mendex Patch

Mendex Patch
SPL v1
SPL
SPL Set ID 07eec701-f579-7394-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2014-11-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g) Capsaicin (.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 2014-11-10

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%

Keep Out of Reach of Children

Keep out of reach of children

Mendex 25 Patches (69329 013 25)






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%

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

Keep out of reach of children

Mendex 25 Patches (69329 013 25) (MENDEX 25 Patches (69329-013-25))






Advanced Ingredient Data


Raw Label Data

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