Bene patch patch

Otc - active ingredient section

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00 %

Menthol 1.00 %


Otc - purpose section

Lidocaine HCL 4.00 % Topical Analgesic

Menthol 1.00 % External Analgesic

Indications & usage section

USES:

For temporary relief of pain associated with minor cuts, scrapes and minor skin irritations

Warnings section

WARNINGS:

  • For external use only.
  • Avoid contact with eyes.
  • Do not apply on open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not bandage tightly.
  • If pregnant or breast feeding, contact physician before use.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Otc - keep out of reach of children section

Keep out of reach of children. If swallowed, consult physician.

Dosage & administration section


DIRECTIONS:

  • Clean and dry affected area.
  • Remove patch from backing and apply to affected area.
  • Use only one patch at a time, and a maximum of four patches / day.
  • Leave patch on affected area for up to 8 hours.
  • Do not use patches for longer than 5 consecutive days.
  • Children under 12 should consult physician prior to use.

Inactive ingredient section

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montana Extract,

Boswellia Serrata Extract, Camelia Sinensis Leaf (Green Tea) Extract, Carbomer, Ethylhexylglycerin,

Glycerin, Isopropyl Myristate, PEG - 8, Phenoxyethanol, Polysorbate - 80, Sodium Lauryl Sulfate,

Triethanolamine, FD C Blue No. 1, FD C Yellow No. 5.

Storage and handling section

Store below 25 degrees

Avoid direct sunlight.

Ingredients and appearance - Product information

Bene patch patch- Lidocaine hcl, menthol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 57900-008
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 1 gin 100 g
Lidocaine hydrochloride ( UNII: V13007Z41A)( Lidocaine - UNII: 98PI200987 ) 4 gin 100 g

Inactive Ingredients

Ingredient Name Code
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Green tea leaf ( UNII: W2ZU1RY8B0)
Glycerin ( UNII: PDC6A3C0OX)
Peg-8 stearate ( UNII: 2P9L47VI5E)
Isopropyl myristate ( UNII: 0RE8K4LNJS)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Aloe vera leaf ( UNII: ZY81Z83H0X)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Sodium lauryl sulfate ( UNII: 368GB5141J)
Trolamine ( UNII: 9O3K93S3TK)
Arnica montana ( UNII: O80TY208ZW)
Indian frankincense ( UNII: 4PW41QCO2M)
Fd&c yellow no. 5 ( UNII: I753WB2F1M)
Ethylhexylglycerin ( UNII: 147D247K3P)
Carbomer homopolymer type c (allyl pentaerythritol crosslinked) ( UNII: 4Q93RCW27E)
Water ( UNII: 059QF0KO0R)

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( 57900-008)

Package label.principal display panel