AVALIN EXTERNAL ANALGESIC PATCH- lidocaine, menthol patch 
RxChange Co.

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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Avalin External Analgesic Patch

Active ingredients

Lidocaine 4%

Menthol 1%

Purpose

External Analgesic

Uses

For the temporary relief pain associated with • minor cuts  • scrapes  • minor skin imitations

Warnings

For external use only

Do not use

• in large quantities, particularly over raw surfaces or blistered areas

• other than directed by a doctor  • on open wounds or damaged skin

• with a bandage to cover the surface  • for longer than 5 consecutive days

Ask a doctor before use

if used for children under 12.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor

• condition worsens  • symptoms persist for more than 7 days

• symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get a medical help or contact Poison Control Center right away.

Directions

Other information

Store in dry area between 59-79 F(15-26 C)

Inactive ingredients

acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

Questions or comments?

Please call (818) 545-1177

Product Label

FrontPanelDrugFacts

AVALIN EXTERNAL ANALGESIC PATCH 
lidocaine, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33358-901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33358-901-1515 in 1 CARTON
1100 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/29/2015
Labeler - RxChange Co. (781126805)

Revised: 1/2015
Document Id: 72035ad0-7153-4429-839c-5c04d5742fd1
Set id: dc00f4b2-f407-4f89-8db7-1c67d610b64b
Version: 1
Effective Time: 20150129
 
RxChange Co.