Calendulax (Calendula Officinalis) Ointment [Nartex Laboratorios Homeopaticos Sa De Cv] -

CALENDULAX (CALENDULA OFFICINALIS) OINTMENT [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]
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NDC	34666-181-01, 34666-181-02
Set ID	5f3c1f9c-bac9-450a-ae61-36be657783ac
Category	HUMAN OTC DRUG LABEL
Packager	Nartex Laboratorios Homeopaticos SA DE CV
Generic Name
Product Class
Product Number
Application Number

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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

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

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)

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