FDA.reportPublic FDA data

SnowBalm Baby

Manufacturer
Snow Pharmaceuticals, LLC
Effective date
2017-03-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:17:27

Label at a glance#

ProductSnowBalm Baby
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash Protects from minor skin irritation due to diaper rash and helps seal out wetness.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 8.5%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses:

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects from minor skin irritation due to diaper rash and helps seal out wetness.

Warnings:

WARNINGS SECTION

For External Use Only.

When using this product

  • do not get into eyes.

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more that 7 days or clear up and occur again within a few days

Keep out of each of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Lanolin, olive oil, petrolatum, thymol iodide

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

Drug FactsDrug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58766-01058766-010-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
OLIVE OIL6UYK2W1W1EIACT
PETROLATUM4T6H12BN9UIACT
THYMOL IODIDEA51HJM3XSUIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cc319175-c695-53c8-e053-2a95a90a3bf77b587b68-2828-48d0-8bce-d607851e768e2021-09-17WarningsExact identifier
spl set id: 7b587b68-2828-48d0-8bce-d607851e768e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.