Label: RELIEF GEL- lidocaine hcl gel

  • NDC Code(s): 73716-003-05, 73716-003-29
  • Packager: Good Clean Love, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 11, 2022

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  • Active ingredients (per dose)

    Lidocaine HCL 4%

  • Purpose

    Lidocaine HCL 4%................Topical Analgesic

  • Uses

    For temporary relief from vaginal pain, itch, and irritation

  • Warnings

    For external use only. Avoid contact with eyes. Do not use on large areas of skin.

    Ask a doctor before use if

    • You are pregnant, trying to conceive, or breastfeeding

    Stop use and ask doctor if

    • Allergic reaction occurs
    • Condition worsens or does not improve
    • Redness, irritation, or swelling occurs

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • Clean area and gently dry irritated area
    • Apply gel to vulva, labia and at the vaginal opening as needed to relieve itching, burning irritation, and to soothe irritated skin
    • Clean nozzle after use & close tightly
    • Do not apply more than 3-4 times daily unless directed by doctor
  • Other information

    • Tamper resistant seal
    • Do not use if seal is not intact
    • Store at room temperature (68F-77F)
  • Inactive ingredients

    Purified Water, Organic Aloe Barbadensis Leaf Juice, Propanediol, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Lactic Acid, Xanthan Gum, St. John’s Wort Extract, Linden Flower Extract, Green Tea Extract, Calendula Extract, Aspen Extract, Cornflower Extract, Roman Chamomile Extract, Sodium Benzoate, Potassium Sorbate, Glycerin

  • Questions or comments?

    1-541-344-4483 Monday-Friday

    9am-5pm or visit goodcleanlove.com

  • PRINCIPAL DISPLAY PANEL

    Good Clean Love

    relief gel

    Pain & Itch Gel

    With Lidocaine 4%

    Relieves irritation & external vaginal discomfort

    Gynecologist Recommended

    1 Fl Oz (29mL)

    1

    2

    3

  • INGREDIENTS AND APPEARANCE
    RELIEF GEL 
    lidocaine hcl gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73716-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    ST. JOHN'S WORT (UNII: UFH8805FKA)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73716-003-291 in 1 CARTON04/08/2022
    129 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73716-003-055 mL in 1 POUCH; Type 0: Not a Combination Product04/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2022
    Labeler - Good Clean Love, Inc. (153909531)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRI-PAC, INC.020844956manufacture(73716-003)
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