Label: LIQUID SEX- lidocaine gel
-
Contains inactivated NDC Code(s)
NDC Code(s): 69797-101-01 - Packager: WSM Investment LLC. Topco Sales
- 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.
Drug Label Information
Updated December 14, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
- For external use only. Do not use product with a mechanical device.
- Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
- Do not exceed the daily recommended dosage.
- Do not apply onto cracked or broken skin.
- In case of any bleeding or irritation, discontinue use and consult a doctor.
-
KEEP OUT OF REACH OF CHILDREN
- Keep this and all drugs out of reach of children. In case of accidental overdose, seek medical help or call a Poison Control Center right away.
- As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
- Do not exceed recommended dosage.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LIQUID SEX
lidocaine gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69797-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2.36 g in 118 mL Inactive Ingredients Ingredient Name Strength DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOPENTYLDIOL (UNII: 19NOL5474Q) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69797-101-01 118 mL in 1 TUBE; Type 0: Not a Combination Product 12/14/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/14/2017 Labeler - WSM Investment LLC. Topco Sales (040346439) Establishment Name Address ID/FEI Business Operations WSM Investment LLC. Topco Sales 040346439 manufacture(69797-101)