Label: GIGI ANESTHETIC NUMBING- lidocaine aerosol
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated May 10, 2010
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- ACTIVE INGREDIENT
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.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GIGI ANESTHETIC NUMBING
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57367-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g Inactive Ingredients Ingredient Name Strength ISOBUTANE (UNII: BXR49TP611) THYMOL (UNII: 3J50XA376E) EUGENOL (UNII: 3T8H1794QW) ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) OLETH-5 (UNII: 1GH33785AY) ISODODECANE (UNII: A8289P68Y2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57367-001-01 42 g in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part348 10/27/1997 Labeler - 220 LABORATORIES INC (783247950) Registrant - 220 LABORATORIES INC (783247950) Establishment Name Address ID/FEI Business Operations 220 LABORATORIES INC 783247950 manufacture