BABYGANICS SOOTHING ITCH- oatmeal stick

Babyganics Soothing Itch by

Drug Labeling and Warnings

Babyganics Soothing Itch by is a Otc medication manufactured, distributed, or labeled by KAS Direct, LLC, Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal oatmeal 10%

Purpose

Skin protectant

Uses

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

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

Warnings

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 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.

Directions

apply as needed

Other information

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

Inactive ingredients

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, tocopherol, solanum lycopersicum (tomato) seed oil, lavandula angustifolia (lavender) oil, anthemis nobilis (chamomile) oil,vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil

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

SPL UNCLASSIFIED SECTION

Dist. by
KAS Direct, LLC
1525 Howe Street
Racine, WI 53403

PRINCIPAL DISPLAY PANEL - 18 g Stick Carton

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)

INGREDIENTS AND APPEARANCE

BABYGANICS SOOTHING ITCH 
oatmeal stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-3301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER SEED (UNII: R9N3379M4Z)
WHITE WAX (UNII: 7G1J5DA97F)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PEPPERMINT OIL (UNII: AV092KU4JH)
Tocopherol (UNII: R0ZB2556P8)
TOMATO SEED OIL (UNII: 7N87T9C06T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-3301-1	1 in 1 CARTON	09/01/2024
1		18 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M016	09/01/2024

Labeler - KAS Direct, LLC (002764605)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Solutions		807907928	MANUFACTURE(59062-3301)