SPL v3
SPL
SPL Set ID 6a98e4b9-2906-4207-83ac-48f41fba190e
Route
TOPICAL
Published
Effective Date 2022-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (534 mg) Lanolin (155 mg)
Inactive Ingredients
Cod Liver Oil Microcrystalline Wax Mineral Oil Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-31

Description

Petrolatum - 53.4 % Lanolin  - 15.5 %

Purpose

Skin Protectant 


Medication Information

Purpose

Skin Protectant 

Description

Petrolatum - 53.4 % Lanolin  - 15.5 %

Uses 
  • helps treat and prevent diaper rash

temporarily protects minor:

  • cuts
  • scrapes
  • burns

temporarily protects and helps relieve chafed, chapped or cracked skin and lips

helps protect from the drying effects of wind and cold weather

Purpose 

Skin Protectant 

Directions
  • for skin protectant use apply as needed for diaper rash use
  • change wet or soiled diapers promptly
  • cleanse the diaper area and allow to dry 
  • apply ointment liberally as often as nessary, with each diaper change, especially at bedtime or anytime when exposed to wet diapers may be prolonged 
Warnings 

For external use only 

when using this product 

  • do not get into eyes

Stop use and ask a doctor if 

  • conditions 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

Drug Fact 

Active Ingredient

Petrolatum - 53.4 %

Lanolin  - 15.5 %

Other Information 

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

Inactive Ingredients 

 Cod Liver Oil (contains Vitamin A & Vitamin D), Fragrance, Microcrystalline Wax, Mineral Oil, Paraffin

Principal Dispaly Panel Tube 

Target Up and Up             NDC 11673-721-40

Vitamin A&D ointment

Petrolatum 53.4%

Lanolin 15.5%

Skin protectant

NET WT 4.0 OZ (113.3g)

Principal Display Panel Carton

Target Up and Up             NDC 11673-721-40

Vitamin A&D ointment 

Petrolatum 53.4%

Lanolin 15.5%

Skin protectant 

NET WT 4.0 OZ (113.3g) 

Keep Out of the Reach of Children

 If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses 
  • helps treat and prevent diaper rash

temporarily protects minor:

  • cuts
  • scrapes
  • burns

temporarily protects and helps relieve chafed, chapped or cracked skin and lips

helps protect from the drying effects of wind and cold weather

Purpose 

Skin Protectant 

Directions
  • for skin protectant use apply as needed for diaper rash use
  • change wet or soiled diapers promptly
  • cleanse the diaper area and allow to dry 
  • apply ointment liberally as often as nessary, with each diaper change, especially at bedtime or anytime when exposed to wet diapers may be prolonged 
Warnings 

For external use only 

when using this product 

  • do not get into eyes

Stop use and ask a doctor if 

  • conditions 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

Drug Fact 

Active Ingredient

Petrolatum - 53.4 %

Lanolin  - 15.5 %

Other Information  (Other information )

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

Inactive Ingredients  (Inactive ingredients )

 Cod Liver Oil (contains Vitamin A & Vitamin D), Fragrance, Microcrystalline Wax, Mineral Oil, Paraffin

Principal Dispaly Panel Tube  (Principal dispaly panel -Tube )

Target Up and Up             NDC 11673-721-40

Vitamin A&D ointment

Petrolatum 53.4%

Lanolin 15.5%

Skin protectant

NET WT 4.0 OZ (113.3g)

Principal Display Panel Carton (Principal display panel -Carton)

Target Up and Up             NDC 11673-721-40

Vitamin A&D ointment 

Petrolatum 53.4%

Lanolin 15.5%

Skin protectant 

NET WT 4.0 OZ (113.3g) 

Keep Out of the Reach of Children (Keep out of the reach of children)

 If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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