ECZEMA SPOT TREATMENT  SKIN PROTECTANT- oatmeal lotion 
KAS Direct LLC dba BabyGanics

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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Eczema Spot Treatment
Skin Protectant

Drug Facts

Active ingredient

Colloidal oatmeal 5%

Purpose

Skin protectant

Uses

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

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

Other information

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

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)

PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton
ECZEMA SPOT TREATMENT   SKIN PROTECTANT
oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1743
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1743-11 in 1 BOX03/15/2019
128.35 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34703/15/2019
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2020
Document Id: eb0c80ed-e5fa-44a0-ae79-2e32cf6b0288
Set id: 6615ecb4-fd23-44aa-b58a-bc08fbe66116
Version: 1
Effective Time: 20200724
 
KAS Direct LLC dba BabyGanics