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  5. Label Information: Sarna

FDA Label for Sarna

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Sarna Product Label

The following document was submitted to the FDA by the labeler of this product Crown Laboratories. 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



Pramoxine Hydrochloride - 1%


Purpose



External analgesic


Uses



  • for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

Warnings



For external use only


When Using This Product



  • avoid contact with the eyes

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • to open, hold cap tightly and turn pump counter-clockwise

    • Adults and children 2 years of age and older:

    • apply to affected area not more than 3 to 4 times daily

      • Children under 2 years of age:

      • consult a doctor

Other Information



Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].


Inactive Ingredients



benzyl alcohol, carbomer homopolymer type C, cetyl alcohol, dimethicone, glyceryl monostearate, isopropyl myristate, petrolatum, polyoxyl 8 stearate, polyoxyl 100 stearate, purified water, sodium hydroxide, stearic acid


Questions Or Comments?



Call 1-833-279-6522


Principal Display Panel



DERMATOLOGIST Recommended

NDC 0316-0230-75

Steroid-Free and Fragrance-Free

Sarna

SENSITIVE

Pramoxine Hydrochloride 1%

EXTERNAL ANALGESIC LOTION

ANTI-ITCH

  • Relieves itching associated with:
  • DRY, SENSITIVE AND ECZEMA PRONE SKIN
  • Moisturizing

    • Net wt. 7.5 fl oz (222 mL)

    Sarna is registered trademark of Crown Laboratories, Inc.

    Distributed by:

    Crown Laboratories, Inc.

    Johson City, TN 37604

    Made in Canada

    ©2018 Crown Laboratories, Inc.

    Front Label: P11543.00


* Please review the disclaimer below.