Ricora
FDA Label NDC 69418-006

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meds Direct Rx, Inc. for the product Ricora (NDC 69418-006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, uses:, warnings:, • keep out of reach of children., if pregnant or breastfeeding,, do not, directions:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients:

Lidocaine HCL 4.00%
Menthol 1.00%

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

Package Lebeling:

Image (Ricorapld1)

Image (Ricorapld1)

Label1 (Label2)

Label1 (Label2)

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