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  5. Label Information: Premier Value Diaper Rash

FDA Label for Premier Value Diaper Rash

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. WARNINGS
    4. OTC - DO NOT USE
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INDICATIONS & USAGE
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. DOSAGE & ADMINISTRATION
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value Diaper Rash 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 Ingredient                                                                     Purpose

Zinc oxide, 40% .....................................................................Skin protectant


Otc - Purpose



Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps protect skin from wetness

Warnings



Warnings

For external use only


Otc - Do Not Use



Do not use

over deep or puncture wounds, infections or lacerations


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


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

  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

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

Inactive Ingredient



Inactive ingredients

BHA, cod liver oil (high in vitamin A and D), fragrance, lanolin, methylparaben, petrolatum, talc and purified water, light mineral oil, tartrazine yellow #4 (FD and C yellow #4)


Dosage & Administration



Distributed By:

Chain Drug Consortium, LLC.

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

Boca Raton, FL 33431


Package Label.Principal Display Panel



image of carton label - PVDiaperRashOintment

image of carton label - PVDiaperRashOintment

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