SPL v3
SPL
SPL Set ID 5a445a96-1652-47e0-b9bb-6e63fc184108
Route
TOPICAL
Published
Effective Date 2022-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (410 mg)
Inactive Ingredients
Light Mineral Oil Ceresin Lanolin Alcohols Glycerin Panthenol Levomenol

Identifiers & Packaging

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

Description

Petrolatum - 41%

Purpose

Skin Protectant 


Medication Information

Purpose

Skin Protectant 

Description

Petrolatum - 41%

Uses

• temporarily protects minor:

• cuts • scrapes • burns

• temporarily protects and helps relieve chapped or cracked skin and lips

• helps protect from the drying effects of wind and cold weather

• helps treat and prevent diaper rash

• protects chafed skin associated with diaper rash and helps protect from wetness

Drug Facts

Directions
  • 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

Do Not Use On 
  • deep punture wounds
  • animal bites
  • serious burns
Active Ingredient

Petrolatum - 41%

Other Information 

Do not use if safety seal is broken

Inactive Ingredients: 

 Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol

Principal Primary Panel Tube

Target Up and Up       NDC 11673-729-85

Baby Healing ointment

Petrolatum 41% Skin protectant

NET WT 3.0 OZ (85g)

Stop Use and Ask A Doctor If 
  • conditions worsens 
  • symptoms last more than 7 days or clear up an occur again within a few days
Keep Out of the Reach of Children

If swallowed, get medical help

or contact a Poison Control Center right away.


Structured Label Content

Uses

• temporarily protects minor:

• cuts • scrapes • burns

• temporarily protects and helps relieve chapped or cracked skin and lips

• helps protect from the drying effects of wind and cold weather

• helps treat and prevent diaper rash

• protects chafed skin associated with diaper rash and helps protect from wetness

Purpose

Skin Protectant 

Drug Facts (DRUG FACTS)

Directions
  • 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

Do Not Use On  (Do not use on )
  • deep punture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Petrolatum - 41%

Other Information  (Other information )

Do not use if safety seal is broken

Inactive Ingredients:  (Inactive ingredients: )

 Mineral Oil, Ceresin, Lanolin Alcohol, Panthenol, Glycerin, Bisabolol

Principal Primary Panel Tube (Principal primary panel -Tube)

Target Up and Up       NDC 11673-729-85

Baby Healing ointment

Petrolatum 41% Skin protectant

NET WT 3.0 OZ (85g)

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • conditions worsens 
  • symptoms last more than 7 days or clear up an occur again within a few days
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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