little me multipurpose baby balm

little me multipurpose baby balm
SPL v1
SPL
SPL Set ID e09518f1-3691-4d85-a8e1-a5c452057066
Route
topical
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
white petrolatum (1000 mg)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-01

Description

White petrolatum USP (100%)


Medication Information

Warnings

For external use only

Directions
  • cleanse the diaper area and pat dry
  • apply product as often as needed, with each diaper diaper change, especially at bedtime or when exposure to wet diapers may be prolonged
Other Information

Store below 86° F (30° C)

Description

White petrolatum USP (100%)

Use
  • helps treat and prevent diaper rash
  • protects chafed skin
  • helps seal out wetness
Section 55105-1

Skin Protectant

Do Not Use

over lacerations, infections,or deep puncture wounds. Ask a doctor.

Drug Facts

Active Ingredient

White petrolatum USP (100%)

Package Labeling:

Questions Or Comments?

Call 1- 800-524-1428

When Using the Product

do not get into eyes. If contact occurs, rinse thoroughly with water.

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 From Children.

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


Structured Label Content

Warnings

For external use only

Directions
  • cleanse the diaper area and pat dry
  • apply product as often as needed, with each diaper diaper change, especially at bedtime or when exposure to wet diapers may be prolonged
Other Information (Other information)

Store below 86° F (30° C)

Use
  • helps treat and prevent diaper rash
  • protects chafed skin
  • helps seal out wetness
Section 55105-1 (55105-1)

Skin Protectant

Do Not Use (Do not use)

over lacerations, infections,or deep puncture wounds. Ask a doctor.

Drug Facts

Active Ingredient

White petrolatum USP (100%)

Package Labeling:

Questions Or Comments? (Questions or Comments?)

Call 1- 800-524-1428

When Using the Product (When using the product)

do not get into eyes. If contact occurs, rinse thoroughly with water.

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 From Children. (Keep out of reach from children.)

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


Advanced Ingredient Data


Raw Label Data

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