CALENDULAX- calendula officinalis ointment
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.

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Drug Facts

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

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

CALENDULAX
calendula officinalis ointment

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

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34666-181-01	1 in 1 CARTON	04/17/2015	01/11/2023
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	01/11/2023
2		28 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/17/2015	01/11/2023

Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)

Name	Address	ID/FEI	Business Operations
Establishment
Nartex Laboratorios Homeopaticos SA DE CV		589914576	manufacture(34666-181)

Revised: 1/2023

Document Id: f229388d-50ae-092a-e053-2995a90aecac

Set id: 5f3c1f9c-bac9-450a-ae61-36be657783ac

Version: 4

Effective Time: 20230113

Nartex Laboratorios Homeopaticos SA DE CV