FDA Label for Premier Value Allergy

View Indications, Usage & Precautions

Premier Value Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Tai Guk Pharm. Co., Ltd.. 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 USP, 2% .........................................Topical analgesic

Zinc acetate, 0.1% .........................................................................Skin Protectant


Otc - Purpose



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



Warnings

For external use only


Otc - Do Not Use



Do not use on large area of the body or with any other product containing diphenhydramine, even one taken by mouth.


Otc - Ask Doctor



Ask a doctor before use

on chicken pox or on measles.


Otc - When Using



When using this product

avoid contact with the eyes.


Otc - Stop Use



Stop use and ask a doctor if condition worsens or does not improve within 7 days, or 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.


Indications & Usage



Directions

  • do not use more than directed
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
  • children under 2 years of age: consult a doctor
  • discontinue use and consult a physician if rash or irritation develops

Storage And Handling



Other information

  • store at 20o to 25oC (68o to 77oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Dosage & Administration



Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd., Suite 101

Boca Raton, FL 33431


Inactive Ingredient



Inactive ingredients

glycerin, sodium chloride, petrolatum, cetyl alcoho, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water, hydroxyethyl cellulose


Package Label.Principal Display Panel



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