Calendula 5% Special Order

CALENDULA 5% SPECIAL ORDER- calendula 5% special order spray
Uriel Pharmacy Inc.

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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Directions: FOR Topical USE ONLY.

Use or as needed. Ages 12 and older: 2-3 sprays. Ages 2-11: 1-2 sprays. Under age 2: Consult a doctor.

Active Ingredients: 100gm spray contain: 5gm Calendula 1X

Inactive Ingredients: Distilled water, Sodium chloride, Tea tree oil, Grapefruit seed extract

Use: Temporary relief of headache.

KEEP OUT OF REACH OF CHILDREN.

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any
ingredient. Consult a doctor before use for
serious conditions or if conditions worsen or
persist. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seals on box are broken or missing.

SHAKE WELL BEFORE USE

Questions? Call 866.642.2858
Made with care by Uriel, East Troy, WI 53120
www.urielpharmacy.com

Calendula5SOSpray

CALENDULA 5% SPECIAL ORDER
calendula 5% special order spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48951-3215
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	1 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:48951-3215-2	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/01/2009

Labeler - Uriel Pharmacy Inc. (043471163)

Name	Address	ID/FEI	Business Operations
Establishment
Uriel Pharmacy Inc.		043471163	manufacture(48951-3215)