SKIN PROTECTANT- colloidal oatmeal ointment

Skin Protectant by

Drug Labeling and Warnings

Skin Protectant by is a Otc medication manufactured, distributed, or labeled by ELAJ, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Colloidal Oatmeal 1.0%

Purpose

Skin Protectant

Uses

Temporarily protects and helps relieve minor skin irritations and itching due to 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 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 or recommended 3-4 x a day initially during flare up and as needed after flareup begins to subside
• Apply generously before bed to help avoid itching while sleeping

Storage

Store at room temperature

Inactive Ingredients

USP White Petrolatum, Lemon Concentrate, Glycerin, Honey, Prunus Amygdalus Dulcis (Almond Oil), Alpha tocopherol (Vitamin E), Beeswax, Soy Wax, Talc, Boric acid, Zinc oxide, Stearic acid, Pistachia lenticus (Mastica), Vanilla

Questions or Comments

1-844-Buy-ELAJ (949-581-1200) or visit www.elajnaturally.com

Product Packaging Labels

57 g, 113 g, and 227 g Box Labels

57 g, 113 g, and 227 g Container Labels

INGREDIENTS AND APPEARANCE

SKIN PROTECTANT 
colloidal oatmeal ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69123-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.57 g  in 57 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
HONEY (UNII: Y9H1V576FH)
ALMOND OIL (UNII: 66YXD4DKO9)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
YELLOW WAX (UNII: 2ZA36H0S2V)
Talc (UNII: 7SEV7J4R1U)
BORIC ACID (UNII: R57ZHV85D4)
ZINC OXIDE (UNII: SOI2LOH54Z)
STEARIC ACID (UNII: 4ELV7Z65AP)
Vanilla (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69123-111-01	1 in 1 BOX
1		57 g in 1 CONTAINER
2	NDC: 69123-111-02	1 in 1 BOX
2		113 g in 1 CONTAINER
3	NDC: 69123-111-03	1 in 1 BOX
3		227 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/25/2014

Labeler - ELAJ, LLC (051975632)

Registrant - ELAJ, LLC (051975632)