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  5. Label Information: Califlora

FDA Label for Califlora

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. DOSAGE & ADMINISTRATION
    3. INDICATIONS & USAGE
    4. OTC - PURPOSE
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. OTC - ASK DOCTOR
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OVERDOSAGE
    10. BOERICKE AND TAFEL BRANDCALIFLOA CALENDULA GEL

Califlora Product Label

The following document was submitted to the FDA by the labeler of this product Schwabe North America, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients:

CALENDULA OFFICINALIS 1X


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.


Otc - 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.

In case of deep cuts or puncture wounds, animal bites or serious burns, consult a physician.

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

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


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.


Otc - Ask Doctor



Ask the Doctor:

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


Otc - Pregnancy Or Breast Feeding



Pregnancy or Breast Feeding:

Breast-feeding women should not apply to breast area.


Overdosage



Overdosage:

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


Boericke And Tafel Brandcalifloa Calendula Gel



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