Gigi Anesthetic Numbing
FDA Label NDC 57367-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by 220 Laboratories Inc for the product Gigi Anesthetic Numbing (NDC 57367-001). 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 otc - active ingredient, otc - purpose, warnings and precautions, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT - LIDOCAINE 4%PURPOSE - NUMBING

Otc - Purpose

Uses: Lidocaine is a topical anesthetic that penetrates the surface of the skin, numbing the area to be epilated within minutes.

Warnings And Precautions

Warnings: For external use only. Avoid spraying in eyes. Do not spray directly on face. Discontinue use if irritation occurs. If accidentally ingested, seek medical assistance immediately. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME. KEEP OUT OF REACH OF CHILDREN.

Dosage & Administration

Directions - Before waxing large areas (legs, backs, arms, underarms and bikini areas) spray directly onto the skin. Do not spray near eyes or mouth. For waxing any part of the face, spray onto cloth, cotton ball or swab. Wait approximately 2-3 minutes for skin to numb, then proceed with waxing service. After waxing, spray or apply with cloth, cotton ball or swab for added comfort.

Package Label.Principal Display Panel

GiGi Anesthetic Numbing Spray
for sensitive skin
Temporarily numbs the skin taking the sting out of waxing while soothing the skin.




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