Recovery Numb Cream
FDA Label NDC 49436-099

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purklenz Formulations Inc. for the product Recovery Numb (NDC 49436-099). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Active Ingredient

→ Otc - Purpose

→ Indications & Usage

→ Warnings

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Other Safety Information

→ Inactive Ingredient

→ Package Label

Other

DRUG FACTS

Otc - Active Ingredient

Active Ingredients: Lidocaine 4% w/w

Otc - Purpose

Purpose: Topical Anesthetic

Indications & Usage

Uses: Temporarily relieves pain and itching
due to minor cuts, minor scrapes, sunburn,
minor skin irritations, minor burns, insect bites.

Warnings

WARNINGS:FOR EXTERNAL USE ONLY.

Otc - When Using

When using this product: Do not use in or
near the eyes; do not use in large quantities;
particularly over raw surfaces or blistered areas.

Otc - Stop Use

Stop use and ask doctor if: Allergic reaction
occurs; condition worsens or does not improve
within 7 days; symptoms clear up and return
within a few days; redness, irritation, swelling,
pain or other symptoms begin or increase.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: If swallowed,
get medical help or contact a Poison Control
Center right away

Dosage & Administration

Directions:Adults and children 2 years and
older: Apply externally to the affected area up
to 3-4 times daily.
Children under 2 years of age: Consult a
doctor.

Other Safety Information

Other Information: Store at room
temperature 20°C and 25°C (68°F to
77°F).

Inactive Ingredient

Inactive ingredients: Benzyl Alcohol,
Carbomer 940, Cholesterol, Hydrogenated
Lecithin, Polysorbate 80, Propylene Glycol,
Tocopherol Acetate, Trolamine, Water