ECZEMA SPOT TREATMENT SKIN PROTECTANT- oatmeal lotion

Eczema Spot Treatment by

Drug Labeling and Warnings

Eczema Spot Treatment 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 5%

Purpose

Skin protectant

Uses

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

• rashes
• eczema

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 to affected areas
• for larger or full body coverage, use Babyganics Eczema Cream

Other information

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

Inactive ingredients

helianthus annuus (sunflower) seed oil1, tapioca starch, castor oil/IPDI copolymer, cocos nucifera (coconut) oil1, butyrospermum parkii (shea) butter1, caprylic/capric triglyceride, helianthus annuus (sunflower) seed wax, simmondsia chinensis (jojoba) seed oil1, solanum lycopersicum (tomato) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, tocopherol

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

SPL UNCLASSIFIED SECTION

dist. by KAS direct, LLC
1600 Stewart Avenue
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

babyganics

ACCEPTED
NATIONALECZEMA.ORG
NATIONAL
ECZEMA
ASSOCIATION

eczema
spot
treatment

skin
protectant

fragrance free
helps to relieve
dry, itchy, irritated
skin ∙ non-allergenic
pediatrician &
dermatologist tested

Discover which of
our ingredients are
Certified Organic
on back of carton.

Net wt 1 OZ (28.35 g)

INGREDIENTS AND APPEARANCE

ECZEMA SPOT TREATMENT   SKIN PROTECTANT
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59062-1743
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
STARCH, TAPIOCA (UNII: 24SC3U704I)
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
JOJOBA OIL (UNII: 724GKU717M)
TOMATO SEED OIL (UNII: 7N87T9C06T)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
Nigella Sativa Seed Oil (UNII: CS4U38E731)
RASPBERRY SEED OIL (UNII: 9S8867952A)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59062-1743-1	1 in 1 BOX	03/15/2019
1		28.35 g in 1 TUBE; 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	03/15/2019

Labeler - KAS Direct LLC dba BabyGanics (002764605)