FDA Label for Intime Cesens
View Indications, Usage & Precautions
Intime Cesens Product Label
The following document was submitted to the FDA by the labeler of this product Nartex Laboratorios Homeopaticos Sa De Cv. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
Otc - Do Not Use
Do not
- apply to wounds or damaged skin
- apply over large areas of the body
- apply inside the vagina
Otc - When Using
When using this product
- avoid contact with eyes or mucous membranes
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, consult a health professional before use.
Otc - 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, purified water, sodium benzoate, xanthan gum
Questions Or Comments?
[email protected] or call 1-877-248-1970 between 9am and 5pm CST.
Other
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)
* Please review the disclaimer below.