FDA Label for Leader Anti Itch Maximum Strength

View Indications, Usage & Precautions

Leader Anti Itch Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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                                                                             Purpose

Diphenhydramine Hydrochloride 2%....................................................Topical analgesic

Zinc acetate 0.1%.............................................................................Skin protectant


Warnings



Warnings

For external use only.


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using



When using this product

  • avoid contact with eyes

Otc - Stop Use



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


Indications & Usage



Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area no more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Storage And Handling



Other information

  • Store between 20 oC and 25 oC (68 oF and 77 oF)

Inactive Ingredient



Inactive ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, and purified water


Dosage & Administration



DISTRIBUTED BY CARDINAL HEALTH

DULIN, OHIO 43017

CIN 2372134

www.myleader.com

1-800-200-6313


Package Label.Principal Display Panel



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