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

Description

White petrolatum USP (100%)

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

Skin Protectant

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
Do Not Use

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

Drug Facts

Active Ingredient

White petrolatum USP (100%)

Other Information

Store below 86° F (30° C)

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

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

Skin Protectant

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
Do Not Use (Do not use)

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

Drug Facts

Active Ingredient

White petrolatum USP (100%)

Other Information (Other information)

Store below 86° F (30° C)

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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