Label: INTIME CESENS gel

  • NDC Code(s): 34666-301-01
  • Packager: Nartex Laboratorios Homeopaticos SA DE CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated December 17, 2020

If you are a consumer or patient please visit this version.

  • INTIME CESENS

  • Drug Facts

  • Active Ingredient

    Calendula officinalis TINC HPUS*

    Chamomilla TINC HPUS*

    Hamamelis virginiana 3x HPUS*

    Hydrastis canadensis 5x HPUS*

    *The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is an homeopathic dilution.

  • Purpose

    Calendula officinalis TINC HPUS*......external vaginal burning

    Chamomilla TINC HPUS*.....burning and vulvar itching

    Hamamelis virginiana 3x HPUS*.....external vaginal irritation

    Hydrastis canadensis 5x HPUS*.....itching and vulvar pruritis

  • USES

    Temporary Relief of external vaginal

    • burning
    • itching
    • irritation.

    Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not

    • apply to wounds or damaged skin
    • apply over large areas of the body
    • apply inside the vagina
  • WHEN USING

    When using this product

    • avoid contact with eyes or mucous membranes
  • STOP USE

    Stop use and ask a doctor if

    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • rash develops.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, consult a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

  • KEEP OUT OF REACH OF CHILDREN

  • 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.

  • Directions

    • adults, cleanse the affected area with an appropriate cleansing wipe
    • apply generously to affeted area up to 2 times daily
    • reappy if needed
  • Other Information

    • store at room temperature
    • do not use if the tube seal is broken or missing. Claims based on traditional homeopathic practice, not accepted medical evidence. Theses uses have not been evaluated by FDA, and product has not been clinically tested.
  • Inactive Ingredients

    Aloe Vera Leaf, citric acid, glycerin, lavander essential oil, potassium sorbate, propylene glycol, purified water, sodium benzoate, xanthan gum

  • Questions or Comments?

    Informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST.

  • SPL UNCLASSIFIED SECTION

    Active Ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects. Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clnically tested.

    Keep carton. It contains important information.

    Product of Mexico / Producto de Mexico

    Distributed by: Nartex Labs, USA, Inc.

    9543 Bissonnet St. STE. 302

    Houston, TX 77036 USA

    www.nartexlabsusa.com

  • PRINCIPAL DISPLAY PANEL

    PDPContains witch hazel

    Intime Cesens

    Calendula, Chamomila, Hamamelis & Hydrastis Gel

    Temporary relief of external vaginal burning, itching and irritation.

    fragrance free. with lavender essential oil. paraben free

    For external use only

    Claims based on traditional homeopathic practice, not acceptd medical evidence. Not FDA evaluated and not clinically tested.

    Homeopathic

    Net Wt. 1.05oz (29.7g)

  • INGREDIENTS AND APPEARANCE
    INTIME CESENS 
    intime cesens gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-301
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE5 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU) HAMAMELIS VIRGINIANA WHOLE3 [hp_X]  in 1 g
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA1 [hp_X]  in 1 g
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-301-0129.7 g in 1 TUBE; Type 0: Not a Combination Product06/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/11/2020
    Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)
    Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nartex Laboratorios Homeopaticos SA DE CV589914576manufacture(34666-301)