RICORA- lidocaine hydrochloride, menthol patch 
Meds Direct Rx, Inc.

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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Ricora Patch

DRUG FACTS:

ACTIVE INGREDIENTS:

Lidocaine HCL 4.00%
Menthol 1.00%

Topical Anesthetic

External Analgesic

USES:

For temporary relief of pain associated with minor: •cuts •scrapes •skin irritations

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 breastfeeding,

contact physician prior to use.

Do not

use in large quantities, particularly over raw surfaces or blistered areas.

DIRECTIONS:

(Adults and Children 12 years of age and over)

• Clean and dry affected area.

• Remove patch from backing and apply to affected area.

• Use only one patch at a time, and 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 INGREDIENTS:

Glyceryl Hydrogenated Rosinate, Hydrated  Silica, Mineral Oil, PEG-400, Polyisobutene, Styrene/Isoprene Copolymer

Creates a warming sensation to the applied area.

Store below 25 degrees. Avoid direct sunlight.

Package Lebeling:

Imagelabel1

RICORA 
lidocaine hydrochloride, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69418-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69418-006-306 in 1 BOX
15 in 1 POUCH
12.3 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 finalpart34811/21/2015
Labeler - Meds Direct Rx, Inc. (064053428)
Establishment
NameAddressID/FEIBusiness Operations
Meds Direct Rx, Inc.064053428repack(69418-006) , relabel(69418-006)

Revised: 12/2015
Document Id: 25d9728f-6a62-65ab-e054-00144ff8d46c
Set id: 2f959976-aa1f-4c8a-8d98-8c7605ce88a1
Version: 3
Effective Time: 20151201
 
Meds Direct Rx, Inc.