PEDIADERMICS ECZEMA 3- colloidal oatmeal, dimethicone cream 
Renu Laboratories, Inc.

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.

----------

pediadermics eczema 3

Active Ingredients

Colloidal oatmeal 0.1%

Dimethicone 2%

Purpose

Skin protectant

Skin protectant

Uses

Temporarily protects sensitive skin and helps relieve minor skin irritation due to eczema. Temporarily helps prevent and relieve chapped or cracked skin.

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Condition worsens

Keep out of reach of children.

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

Directions

For best results, follow the rule of "3"

Inactive Ingredients

1,2 Hexanediol, Ascorbyl Palmitate, Bio-Saccharide 1, Candelilla / Jojoba / Rice bran, Polyglyceryl-3 Esters, Glyceryl Stearate, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Caprylyl Glycol, Glycerin, Caprylhydroxamic Acid, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cetyl Alcohol, Cholesterol, Deionized Water, Helianthus Annuus (Sunflower) Seed Wax, Limnanthes Alba (Meadowfoam) Seed Oil, Niacinamide, Ophiopogon Japonicus Root Extract, Maltodextrin, Phytosphingosine, Propanediol, Saccharide Isomerate, Sodium EDTA, Sodium Hyaluronate, Sodium PCA, Stearic Acid, Tocopherol, Xanthan Gum

Other information

Store at room temperature.

Questions?

pediadermics@gmail.com

eczema 3

skin barrier repair cream

Eczema 3 Tube Art

ECZEMA 3 tube artwork

PEDIADERMICS ECZEMA 3 
colloidal oatmeal, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-580
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3.36 g  in 168 g
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.168 g  in 168 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
JOJOBA OIL (UNII: 724GKU717M)  
RICE BRAN (UNII: R60QEP13IC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
CANDELILLA WAX (UNII: WL0328HX19)  
PROPANEDIOL (UNII: 5965N8W85T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
PALMITIC ACID (UNII: 2V16EO95H1)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CERAMIDE NP (UNII: 4370DF050B)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CERAMIDE AP (UNII: F1X8L2B00J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HEXANEDIOL (UNII: ZIA319275I)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
OAT (UNII: Z6J799EAJK)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-580-06168 g in 1 TUBE; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2020
Labeler - Renu Laboratories, Inc. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
Renu Laboratories, Inc.945739449manufacture(76348-580)

Revised: 1/2022
Document Id: d5c9dd2c-b8ec-1406-e053-2995a90a0287
Set id: af861f0b-4387-6861-e053-2995a90a8bfa
Version: 2
Effective Time: 20220117
 
Renu Laboratories, Inc.