CALENDULAX- calendula officinalis ointment

Calendulax by

Drug Labeling and Warnings

Calendulax 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]

Active Ingredients

Calendula officinalis....TINC

Purpose

Calendula officinalis....TINC................Wound healing, superficial burns and scalds

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  TINC is a homeopathic dilution: see www.nartexlabusa.com for details.

Uses

Temporarily relieves symptoms associated with minor skin wounds and superficial burns.

Product Uses are based on Homeopathic Materia Medica.  These Uses have not been evaluated by the Food and Drug Administration.  This product has not been clinically tested by Nartex Labs USA, Inc.

Warnings

For external use only

Do not use

• if you have an allergy or hypersensitivity to components of the formula or if you have had a prior reaction to this product
• on deep or puncture wounds
• on animal bites
• on serious burns
• on broken skin

Ask a doctor before use if you are

•    under a doctor's care for any serious condition
•    taking any other drug

When using this product

• avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

• symptoms persist, worse, or if new symptoms occur after 7 days
• rash develops

If pregnant or breast feeding, ask 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

• for minor wounds and burns, immediately run cool water on the wound or burn for several minutes and dry
• apply a thin layer to affected area 3 times a day or as needed
• children under 12 year of age, consult a physician
  

Other Information

• do not use if plastic seal around cap is broken or missing
• store in a cool and dry place
  

Inactive Ingredients

Glycerin, Lanolin wax, Paraffin wax, Sodium benzoate, Water, White petrolatum

Questions or comments?

1-877-248-1970, between 9am and 5pm PT.
informacion@nartexlabs.com

DESCRIPTION

Distributed by:

Nartex Labs USA, Inc.
11711 Memorial dr #685
Houston TX 77024
www.nartexlabusa.com

Principal Display Panel

Calendulax

ointment

Temporarily relieves symptoms associated with

Minor skin wounds
Superficial burns

INGREDIENTS AND APPEARANCE

CALENDULAX  
calendula officinalis ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34666-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	2.973 g  in 28.35 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34666-181-01	1 in 1 CARTON	04/17/2015
1		28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 34666-181-02	1 in 1 CARTON	05/15/2017
2		28 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/17/2015

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(34666-181)