Premier Value Allergy
FDA Label NDC 68169-0127

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Tai Guk Pharm. Co., Ltd. for the product Premier Value Allergy (NDC 68169-0127). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Image Of Carton Label (Pvallergycream)

Image Of Carton Label (Pvallergycream)

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