Intime Cesens: Homeopathic Product Information

INTIME CESENS- hydrastis canadensis whole, hamamelis virginiana whole, calendula officinalis whole and matricaria chamomilla gel
Nartex Laboratorios Homeopaticos SA DE CV

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 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

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

When using this product

  • avoid contact with eyes or mucous membranes

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.

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

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, purified water, sodium benzoate, xanthan gum

Questions or Comments?

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

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

Contains 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)

PDP
(click image for full-size original)
INTIME CESENS
intime cesens gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:34666-301
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDRASTIS CANADENSIS WHOLE (HYDRASTIS CANADENSIS WHOLE) HYDRASTIS CANADENSIS WHOLE 5 [hp_X] in 1 g
HAMAMELIS VIRGINIANA WHOLE (HAMAMELIS VIRGINIANA WHOLE) HAMAMELIS VIRGINIANA WHOLE 3 [hp_X] in 1 g
CALENDULA OFFICINALIS WHOLE (CALENDULA OFFICINALIS WHOLE) CALENDULA OFFICINALIS WHOLE 1 [hp_X] in 1 g
MATRICARIA CHAMOMILLA (MATRICARIA CHAMOMILLA) MATRICARIA CHAMOMILLA 1 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
LAVENDER OIL
SODIUM BENZOATE
CITRIC ACID MONOHYDRATE
GLYCERIN
XANTHAN GUM
WATER
POTASSIUM SORBATE
ALOE VERA LEAF
Product Characteristics
Color Score
Shape FREEFORM Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:34666-301-01 29.7 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 06/11/2020
Labeler — Nartex Laboratorios Homeopaticos SA DE CV (589914576)
Registrant — Nartex Laboratorios Homeopaticos SA DE CV (589914576)
Establishment
Name Address ID/FEI Operations
Nartex Laboratorios Homeopaticos SA DE CV 589914576 manufacture (34666-301)

Revised: 10/2020 Nartex Laboratorios Homeopaticos SA DE CV

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