SOOTHING ITCH SKIN PROTECTANT- oatmeal stick

Soothing Itch by

Drug Labeling and Warnings

Soothing Itch by is a Otc medication manufactured, distributed, or labeled by KAS Direct LLC dba BabyGanics. 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, 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

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

SOOTHING ITCH   SKIN PROTECTANT
oatmeal stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-3300
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 OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
PEPPERMINT OIL (UNII: AV092KU4JH)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
TOMATO SEED OIL (UNII: 7N87T9C06T)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-3300-1	1 in 1 CARTON	02/15/2021
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 FINAL	part347	02/15/2021

Labeler - KAS Direct LLC dba BabyGanics (002764605)