Ricora Patch

Ricora Patch
SPL v3
SPL
SPL Set ID 2f959976-aa1f-4c8a-8d98-8c7605ce88a1
Route
TOPICAL
Published
Effective Date 2015-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 mg)
Inactive Ingredients
Hydrated Silica Mineral Oil Polyethylene Glycol 400

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-11-21

Description

Lidocaine HCL 4.00% Menthol 1.00%


Medication Information

Description

Lidocaine HCL 4.00% Menthol 1.00%

Uses:

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

Do Not

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

Section 42229-5

Creates a warming sensation to the applied area.

Store below 25 degrees. Avoid direct sunlight.

Section 55105-1

Topical Anesthetic

External Analgesic

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.

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.

Package Lebeling:

Active Ingredients:

Lidocaine HCL 4.00%

Menthol 1.00%

Inactive Ingredients:

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

If Pregnant Or Breastfeeding,

contact physician prior to use.

• Keep Out of Reach of Children.

If swallowed, consult physician.

• Do not bandage tightly.


Structured Label Content

Uses: (USES:)

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

Do Not (Do not)

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

Section 42229-5 (42229-5)

Creates a warming sensation to the applied area.

Store below 25 degrees. Avoid direct sunlight.

Section 55105-1 (55105-1)

Topical Anesthetic

External Analgesic

Warnings: (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.

Directions: (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.

Package Lebeling:

Active Ingredients: (ACTIVE INGREDIENTS:)

Lidocaine HCL 4.00%

Menthol 1.00%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

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

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

contact physician prior to use.

• Keep Out of Reach of Children. (• Keep out of reach of children.)

If swallowed, consult physician.

• Do not bandage tightly.


Advanced Ingredient Data


Raw Label Data

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