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  5. Label Information: Calamine Phenolated Topical Suspension

FDA Label for Calamine Phenolated Topical Suspension

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS (SHAKE WELL BEFORE USING)
    8. OTHER INFORMATION.
    9. INACTIVE INGREDIENTS.
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Calamine Phenolated Topical Suspension Product Label

The following document was submitted to the FDA by the labeler of this product Amerisource Bergen. 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.

Active Ingredient



Calamine 8%

Zinc Oxide 8%

Liquefied Phenol


Purpose



Skin Protectant

Skin Protectant

Topical Analgesic


Uses



Dries the oozing and weeping and temporarily pain and itching of poison ivy, poison oak, and poison sumac, or other minor skin irritations


Warnings



  • For external use only. Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to large areas of the body or in large quantities, particularly over raw or blistered areas.
  • If applied to fingers or toes do not bandage.

Ask A Doctor



before using on children under 2 years of age.

When using this product. Discontinue use if condition worsen or does not improve within 7 days and consult a doctor.


Keep Out Of Reach Of Children.



In case of accidental ingestion, seek professional assistance or contact a poison Control Center immediately.


Directions (Shake Well Before Using)



Adult and children 2 years of age and older: Cleanse the skin with soap and water and let dry before each use. Apply product to the affected area using cotton or soft cloth, as often as needed for comfort.

Children under 2 years of age: Consult a doctor before use.


Other Information.



Store at room temperature 15-30C (59-86F)


Inactive Ingredients.



Bentonite Magma, Calcium Hydroxide, Glycerin, Purified Water.


Questions Or Comments?



1-800-662-3435  www.goodneighborpharmacy.com


Principal Display Panel



Good Neighbor Pharmacy    NDC 24385-407-96

Calamine Topical Suspension USP

External Analgesic/Skin Prtectant

Phenolated

6FL OZS (177 mL)

image description - L040796006 GNP CALAMINE PHENOLATED

image description - L040796006 GNP CALAMINE PHENOLATED


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