Ameri patch patch

Otc - active ingredient section

ACTIVE INGREDIENTS:

Menthol 5.00 %

Capsaicin 0.0375%


Otc - purpose section

Menthol 5.00 % Analgesic/Counterirritant

Capsaicin 0.0375% External Analgesic

Indications & usage section

USES:

Use for the temporary relief of minor aches and muscle pains associated with

arthritis, simple backache, strains, muscle soreness and stiffness.

Warnings section

WARNINGS:

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

Otc - keep out of reach of children section

Keep out of reach of children. Consult Physician for children under 12.

Dosage & administration section

DIRECTIONS:

  • Adults and children 12 years and over apply directly 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 and water after applying patch
    • Reseal pouch containing unused patches

Inactive ingredient section

OTHER INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe

Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,

Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcarbamate,

Propylparaben

Storage and handling section

Store below 25 degrees

Avoid direct sunlight.

Ingredients and appearance - Product information

Ameri patch patch- Menthol, capsaicin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 57900-007
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 5 gin 100 g
Capsaicin ( UNII: S07O44R1ZM)( Capsaicin - UNII: S07O44R1ZM ) .0375 gin 100 g

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Glycerin ( UNII: PDC6A3C0OX)
Sodium polyacrylate (2500000 mw) ( UNII: 05I15JNI2J)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Aloe vera leaf ( UNII: ZY81Z83H0X)
Edetate disodium ( UNII: 7FLD91C86K)
Diazolidinyl urea ( UNII: H5RIZ3MPW4)
Methylparaben ( UNII: A2I8C7HI9T)
Iodopropynyl butylcarbamate ( UNII: 603P14DHEB)
Propylparaben ( UNII: Z8IX2SC1OH)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Zhejiang Bangli Medical Products Co., Ltd( 421295875)

Establishment

Name ID/FEI Business Operations
Zhejiang Bangli Medical Products Co., Ltd 421295875 manufacture( 57900-007)

Package label.principal display panel