Soothing Itch

Manufacturer
KAS Direct LLC dba BabyGanics
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:07

Label at a glance#

ProductSoothing Itch Skin Protectant
Active ingredientoatmeal
Label structure10 sections

Indications and uses

temporarily protects and helps relieve minor skin irritation and itching due to: insect bites rashes poison ivy, oak or sumac

Dosage and administration

apply as needed

Storage and handling

store at room temperature 59-77°F (15-25°C) keep carton for complete information

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 10%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

temporarily protects and helps relieve minor skin irritation and itching due to:

  • insect bites
  • rashes
  • poison ivy, oak or sumac

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59-77°F (15-25°C)
  • keep carton for complete information

Inactive ingredients

INACTIVE INGREDIENT SECTION

helianthus annuus (sunflower) seed oil1, cera alba (beeswax)1, cocos nucifera (coconut) oil1, ricinus communis (castor) seed oil1, butyrospermum parkii (shea) butter1, calendula officinalis (calendula) flower oil1, mentha piperita (peppermint) oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, solanum lycopersicum (tomato) seed oil, tocopherol, lavandula angustifolia (lavender) oil, anthemis nobilis (chamomile) oil

1 Certified Organic Ingredient. Unless otherwise specified product not labeled as organic.

SPL UNCLASSIFIED SECTION

dist. by KAS Direct, LLC
San Francisco, CA
94111

PRINCIPAL DISPLAY PANEL - 18 g Applicator Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

babyganics®

soothing
itch stick

skin protectant

colloidal oatmeal* helps
relieve irritation caused by
insect bites & rashes

made without parabens,
phthalates, cortisone, steroids,
dyes, fragrances

Discover which of our ingredients are
certified organic on the back panel.

NET WT 0.64 OZ (18 g)

PRINCIPAL DISPLAY PANEL - 18 g Applicator Carton
PRINCIPAL DISPLAY PANEL - 18 g Applicator Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1745093colloidal oatmeal 10 % Topical OintmentPSN1
1745093colloidal oatmeal 0.1 MG/MG Topical OintmentSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-3300-12023-07-28C16284748780-10191ceaa-64c0-198a-e063-dbdaa90aec3eSoothing Itch Stick Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-3300-1Soothing Itch Skin Protectant18 g in 1 APPLICATORSTICK181
59062-3300-1Soothing Itch Skin Protectant1 in 1 CARTONSTICK11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-3300SOOTHING ITCH SKIN PROTECTANT (OATMEAL) STICK [KAS DIRECT LLC DBA BABYGANICS]1Legacy NDC, 2 package rows20210215_484fb520-91ec-479b-a6a3-9b0074da907d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59062-330059062-3300-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

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
8226169e-b299-47f9-953d-a10065f48593484fb520-91ec-479b-a6a3-9b0074da907d2021-01-15WarningsExact identifier
spl id: 8226169e-b299-47f9-953d-a10065f48593
spl set id: 484fb520-91ec-479b-a6a3-9b0074da907d

Reported adverse events (FAERS/openFDA)#

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