FDA Label for Sunmark Anti-itch

View Indications, Usage & Precautions

Sunmark Anti-itch Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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.

Other



Drug Facts

Distributed by McKesson
One Post Street
San Francisco, CA 94104


Otc - Purpose



Active ingredientsPurpose
Diphenhydramine hydrochloride 2%Topical analgesic
Zinc acetate 0.1%Skin protectant

Uses



  • temporarily relieves pain and itching associated with:
    • insect bites
    • minor burns
    • sunburn
    • minor skin irritations
    • minor cuts
    • scrapes
    • rashes due to poison ivy, poison oak, and poison sumac
    • dries the oozing and weeping of poison ivy, poison oak, and poison sumac

Warnings



For external use only


Do Not Use



  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask A Doctor Before Use



  • on chicken pox
  • on measles

When Using This Product



  • avoid contact with eyes

Stop Use And Ask A Doctor If



  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • do not use more often than directed
  • 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: ask a doctor

Other Information



  • To open: unscrew cap, use pointed end of cap to puncture seal.
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients



cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water


Questions?



Call 1-866-923-4914


Principal Display Panel - 28.4 G Tube Carton



sunmark®

anti-itch cream 2%

diphenhydramine hydrochloride

Topical Analgesic/Antihistamine
Skin Protectant

EXTRA STRENGTH

NET WT 1 OZ (28.4 g)


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