RICORA- lidocaine hydrochloride, menthol patch

Ricora by

Drug Labeling and Warnings

Ricora by is a Otc medication manufactured, distributed, or labeled by Meds Direct Rx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

Creates a warming sensation to the applied area.

Store below 25 degrees. Avoid direct sunlight.

Package Lebeling:

INGREDIENTS AND APPEARANCE

RICORA 
lidocaine hydrochloride, menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69418-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MINERAL OIL (UNII: T5L8T28FGP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69418-006-30	6 in 1 BOX
1		5 in 1 POUCH
1		2.3 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/21/2015

Labeler - Meds Direct Rx, Inc. (064053428)

Establishment
Name	Address	ID/FEI	Business Operations
Meds Direct Rx, Inc.		064053428	repack(69418-006) , relabel(69418-006)