SPL v2
SPL
SPL Set ID 5c49dfbc-39d7-42ab-add6-3a60b4f5479e
Route
TOPICAL
Published
Effective Date 2017-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Petrolatum (41 g)
Inactive Ingredients
Mineral Oil Ceresin Lanolin Alcohols Panthenol Glycerin .alpha.-bisabolol, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-08-06

Description

Petrolatum 41%

Purpose

Skin protectant (ointment) Treatment or prevention of diaper rash


Medication Information

Purpose

Skin protectant (ointment) Treatment or prevention of diaper rash

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

Warnings

For external use only

Directions

apply as needed

for diaper rash, 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.

Tube Label

Carton Label

Do Not Use On

For external use only.  Avoid contact with eyes.  Do not use on serious burns, puncture wounds or animal bites.  If condition does not improve within seven days, consult a doctor.

Active Ingredient

Petrolatum 41%

Inactive Ingredients

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

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.

Keep Out of 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 (ointment) Treatment or prevention of diaper rash

Warnings

For external use only

Directions

apply as needed

for diaper rash, 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.

Tube Label

Carton Label

Do Not Use On (Do not use on)

For external use only.  Avoid contact with eyes.  Do not use on serious burns, puncture wounds or animal bites.  If condition does not improve within seven days, consult a doctor.

Active Ingredient

Petrolatum 41%

Inactive Ingredients (Inactive ingredients)

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

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.

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.


Advanced Ingredient Data


Raw Label Data

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