AFLEXERYL-LC- menthol and lidocaine hydrochloride patch 
Easy Distributors, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Aflexeryl-LC Patch

ACTIVE INGREDIENTS

Lidocaine HCl             4.00%

Menthol                     1.00%

PURPOSE

Topical Analgesic

External Analgesic

USES:

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

Warnings:

  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to open wounds or damaged skin.
  • If swallowed, consult a physician
  • Do not bandage tightly.

  • Do not use in combination with any other external analgesic products..
  • Do not use with any bandage, wrap, stocking or similar device or garment.

  • If symptoms persist for more than 7 days, discontinue and consult a physician.

  • Stop use and consult a physician if symptoms worsen or persist for more than 7 days.

  • If pregnant or breast feeding, contact physician prior to use.

  • Keep out of reach of children. Children under 12 should consult physician prior to use.

Directions:

• Adults and children 12-years and over: Apply to affected area.

• Children under 12, consult a physician before use.

• How to Apply:

   Clean and dry affected area.

   Remove patch from backing and apply directly to affected area.

   Use only one patch at a time, and maximum of four patches per day.

   Leave patch on affected area for up to 8-hours.

   Do not use patches for longer than five consecutive days.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cameila Sinensis (Green Tea) Extract, Carbomer, Ethylhexylglycerin, Glycerin, Isopropyl Myristate, Peg-8, Phenoxyethanol, Polysorbate 80, Sodium Lauryl Sulfate, Triethanolamine, Fd&C Blue #1, Fd&C Yellow #5.

*Store at room temperature. Avoid direct sunlight

Distributed by:

Easy Distributors, LLC

15300 Jog Road Ste # 208

Delray Beach, FL 33446

Package Label

Aflexeryl-LC PATCH

(Lidocaine 4% / Menthol 1%)

Qty 15 Patches

FrontLC

BackLC

AFLEXERYL-LC 
menthol and lidocaine hydrochloride patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69532-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RACEMENTHOL (UNII: YS08XHA860) (RACEMENTHOL - UNII:YS08XHA860) RACEMENTHOL1 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
ARNICA MONTANA (UNII: O80TY208ZW)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE (UNII: 9O3K93S3TK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69532-003-1515 in 1 BOX01/14/201501/05/2016
18 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/14/201501/05/2016
Labeler - Easy Distributors, LLC (079674338)
Establishment
NameAddressID/FEIBusiness Operations
SmartData (Suzhou) Co., Ltd.529507479manufacture(69532-003)

Revised: 1/2016
 
Easy Distributors, LLC