Ricora (Lidocaine Hydrochloride, Menthol) Patch [Meds Direct Rx, Inc.] -

RICORA (LIDOCAINE HYDROCHLORIDE, MENTHOL) PATCH [MEDS DIRECT RX, INC.]
PDF | XML

NDC	69418-006-30
Set ID	2f959976-aa1f-4c8a-8d98-8c7605ce88a1
Category	HUMAN OTC DRUG LABEL
Packager	Meds Direct Rx, Inc.
Generic Name
Product Class	Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number	PART348

View All Sections

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/21/2015

Labeler - Meds Direct Rx, Inc. (064053428)

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

View All Sections

Medic