CALIFLORA CALENDULA GEL- calendula officinalis flowering top gel

Califlora Calendula Gel by

Drug Labeling and Warnings

Califlora Calendula Gel by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe Mexico S.A. de D.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

CALENDULA OFFICINALIS 1X

INACTIVE INGREDIENT

CARBOMER HOMOPOLYMER TYPE C (Polyacrylic Acid)

ETHYL ALCOHOL

PURIFIED WATER

SODIUM HYDROXIDE

WITCH HAZEL DISTILLATE

DOSAGE & ADMINISTRATION

Boericke and Tafel Brand:

Directions:

For minor burns, first run cool water on the burn area and dry.

For minor skin irritation, first wash the area with mild soap, rinse and dry.

Adults and children 2 years of age and older:

Apply to affected area.

Repeat as necessary.

Children under 2 years of age:

Consult a doctor

Patch test recommended on sensitive skin.

INDICATIONS & USAGE

Indications and Use:

Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.

Helps promote healing of minor burns and skin irritations.

PURPOSE

Purpose:

Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.

Helps promote healing of minor burns and skin irritations.

WARNINGS

Warnings:

For external use only. Avoid contact with eyes.

Do not use on broken skin.

Do not use if hypersensitive to any ingredients in this product.

Breast-feeding women shoud ot apply to breast area.

Ask a doctor before use in case of deep cuts or puncture wounds, animal bites or serious burns.

OVERDOSAGE

Overdosage:

If swallowed, seek medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALIFLORA CALENDULA GEL 
calendula officinalis flowering top gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68466-0007
Route of Administration	TOPICAL, 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	1 [hp_X]  in 78 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
sodium hydroxide (UNII: 55X04QC32I)
WITCH HAZEL (UNII: 101I4J0U34)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68466-0007-8	1 in 1 CARTON	01/01/2006
1		78 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68466-0007-4	1 in 1 CARTON	01/01/2006
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2006

Labeler - Schwabe Mexico S.A. de D.V (812805901)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico S.A. de D.V		812805901	manufacture(68466-0007)