CALIFLORA- calendula officinalis gel

Califlora by

Drug Labeling and Warnings

Califlora by is a Homeopathic medication manufactured, distributed, or labeled by Schwabe North America, Inc, Schwabe Mexico, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

CALENDULA OFFICINALIS 1X

Inactive Ingredients:

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 and Use:

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

Helps promote healing of minor burns and skin irritations.

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.

Keep out of the reach of children.

Ask the Doctor:

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

Pregnancy or Breast Feeding:

If pregant or breast-feeding, ask a healthcare professional before use.

OVERDOSAGE

Overdosage:

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

Boericke and Tafel BrandCalifloa Calendula Gel 

INGREDIENTS AND APPEARANCE

CALIFLORA 
calendula officinalis gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53499-5190
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	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: 53499-5190-8	1 in 1 CARTON	01/01/2006
1		78 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53499-5190-4	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 North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-5190)