1. Home
  2. Labeler Index
  3. Universal Distribution Centre Llc
  4. 52000-073
  5. Label Information: Diaper Rash Skin Protectant

FDA Label for Diaper Rash Skin Protectant

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. DO NOT USE ON
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL - 35.4G CARTON

Diaper Rash Skin Protectant Product Label

The following document was submitted to the FDA by the labeler of this product Universal Distribution Centre 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.

Otc - Purpose



Active ingredientsPurpose
Lanolin 15.5%Diaper rash ointment
Petrolatum 53.4%Skin Protectant

Uses



  • helps treat and prevent diaper rash
  • temporarily protects minor:
    • cuts
    • scrapes
    • burns
    • temporarily protects and helps relieve chapped, chafed or cracked skin and lips
    • protect chafed skin due to diaper rash and helps seal out wetness

Warnings



For external use only


When Using This Product



  • do not get into eyes

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Do Not Use On



  • deep or puncture wounds
  • animal bites
  • serious burns

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



  • for skin protectant use apply as needed
  • for diaper rash use:
    • 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

Other Information



store between 20°C to 25 °C (68° to 77°F)


Inactive Ingredients



cod liver oil ( contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin


* Please review the disclaimer below.