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  5. Label Information: Arniflora

FDA Label for Arniflora

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INACTIVE INGREDIENT
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. OTC - PURPOSE
    6. WARNINGS
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - ASK DOCTOR
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OVERDOSAGE
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL:BOERICKE AND TAFEL ARNIFLORA GEL21825090  28 GM 21825097  78 GM

Arniflora 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 Ingredient:

ARNICA MONTANA  1X 


Inactive Ingredient



Inactive Ingredients:

CARBOMER HOMOPOLYMER TYPE C

ETHYL ALCOHOL

PURIFIED WATER

SODIUM HYDROXIDE 

WITCH HAZEL DISTILLATE


Dosage & Administration



Dosage and Administration:

Boericke and Tafel Brand:

Directions:

Apply thin layer to affected area

Massage gently or use compress.

For best results, use promptly after injury or trauma occurs

Adults and Children 2 years of age and older:  apply to affected area up to 4 times daily

Children under 2: Consult a doctor.

Patch test recommened on sensitive skin


Indications & Usage



Indications and Usage:

Temporarily relievews muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises


Otc - Purpose



Purpose:

Temporarily relieves muscle pain, stiffness, and swelling associated with overexertion, sprains, falls, blows, and minor sports injuries.

Reduces pain, swelling, and discoloration from bruises


Warnings



Warnings: 

For external use only.

Avoid contact with eyes or broken skin.

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


Otc - Keep Out Of Reach Of Children



Keep out of Reach of Children:

Keep out of reach of children.


Otc - Ask Doctor



Ask the Doctor:

If skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days or if symptoms clear up and occur againin within a few days.

This could be signs for a serious condition.


Otc - Pregnancy Or Breast Feeding



OTC - Pregnancy or Breast Feeding
Breast-feeding women should not apply to breast area.


Overdosage



Overdose

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


Package Label.Principal Display Panel:Boericke And Tafel Arniflora Gel21825090  28 Gm 21825097  78 Gm



ARNIFLORA_21825090_05


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