AVALIN EXTERNAL ANALGESIC PATCH- lidocaine, menthol patch

Avalin External Analgesic Patch by

Drug Labeling and Warnings

Avalin External Analgesic Patch by is a Otc medication manufactured, distributed, or labeled by RxChange Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
• Children under 2 years of age: Consult a doctor.
• Clean and dry affected area.
• Remove patch from backing and apply to affected area.
• Use one patch at a time.
• Leave patch on affected area for up to 8-hours at a time

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

INGREDIENTS AND APPEARANCE

AVALIN EXTERNAL ANALGESIC PATCH 
lidocaine, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33358-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33358-901-15	15 in 1 CARTON
1		100 g in 1 PATCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/29/2015

Labeler - RxChange Co. (781126805)