Diaper Rash Ointment

Diaper Rash Ointment
SPL v2
SPL
SPL Set ID 29b5475d-6085-cfe6-e063-6294a90a7e74
Route
TOPICAL
Published
Effective Date 2021-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lanolin (136.4 mg) Petrolatum (469.9 mg)
Inactive Ingredients
Cod Liver Oil Light Mineral Oil Microcrystalline Wax Paraffin

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-25

Description

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981


Medication Information

Description

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

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
Section 42229-5

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1
Active ingredients Purpose
Lanolin 15.5% Diaper rash ointment
Petrolatum 53.4% Skin Protectant
Warnings

For external use only

Directions
  • for skin protectant useapply 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
Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
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

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
Principal Display Panel 35.4g Carton


Structured Label Content

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
Section 42229-5 (42229-5)

Distributed by Bayer HealthCare LLC, Whippany, NJ, USA, 07981

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)
Active ingredients Purpose
Lanolin 15.5% Diaper rash ointment
Petrolatum 53.4% Skin Protectant
Warnings

For external use only

Directions
  • for skin protectant useapply 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
Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Other Information (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

When Using This Product (When using this product)
  • do not get into eyes
Stop Use and Ask A Doctor If (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
Principal Display Panel 35.4g Carton (PRINCIPAL DISPLAY PANEL - 35.4g Carton)


Advanced Ingredient Data


Raw Label Data

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