SKIN PROTECTANT- colloidal oatmeal ointment 
ELAJ, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SKIN PROTECTANT

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

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 Box Labels

57 g, 113 g, and 227 g Container Labels

57 g, 113 g, and 227 g Container Labels

SKIN PROTECTANT 
colloidal oatmeal ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69123-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.57 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69123-111-011 in 1 BOX
157 g in 1 CONTAINER
2NDC:69123-111-021 in 1 BOX
2113 g in 1 CONTAINER
3NDC:69123-111-031 in 1 BOX
3227 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/25/2014
Labeler - ELAJ, LLC (051975632)
Registrant - ELAJ, LLC (051975632)

Revised: 7/2014
Document Id: 7d1c93bb-808e-4e8d-9670-af940f07a4bc
Set id: 6537167b-4f8a-485e-bf20-b23d55d5437c
Version: 1
Effective Time: 20140725
 
ELAJ, LLC