Intime Cesens by Nartex Laboratorios Homeopaticos SA DE CV INTIME CESENS gel

Intime Cesens by

Drug Labeling and Warnings

Intime Cesens by is a Homeopathic medication manufactured, distributed, or labeled by Nartex Laboratorios Homeopaticos SA DE CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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)

INGREDIENTS AND APPEARANCE

INTIME CESENS 
intime cesens gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-301
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T)	HYDRASTIS CANADENSIS WHOLE	5 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU)	HAMAMELIS VIRGINIANA WHOLE	3 [hp_X]  in 1 g
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	1 [hp_X]  in 1 g
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H)	CALENDULA OFFICINALIS WHOLE	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape	FREEFORM	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-301-01	29.7 g in 1 TUBE; Type 0: Not a Combination Product	06/11/2020

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	Business Operations
Nartex Laboratorios Homeopaticos SA DE CV		589914576	manufacture(34666-301)