PEDIADERMICS ECZEMA 3- colloidal oatmeal, dimethicone cream

pediadermics eczema 3 by

Drug Labeling and Warnings

pediadermics eczema 3 by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Colloidal oatmeal 0.1%

Dimethicone 2%

PURPOSE

Purpose

Skin protectant

Skin protectant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

WHEN USING

When using this product

• Do not get into eyes
• Do not apply before bathing or showering

STOP USE

Stop use and ask a doctor if

Condition worsens

• Symptoms last more than 2 weeks or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

For best results, follow the rule of "3"

• Apply liberally to skin at least "3" times a day
• Apply within "3" minutes of bathing
• Keep a "3" location supply (Home, On-the-Go and School) !

INACTIVE INGREDIENT

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 SAFETY INFORMATION

Other information

Store at room temperature.

QUESTIONS

Questions?

pediadermics@gmail.com

STATEMENT OF IDENTITY

eczema 3

skin barrier repair cream

PRINCIPAL DISPLAY PANEL

ECZEMA 3 tube artwork

INGREDIENTS AND APPEARANCE

PEDIADERMICS ECZEMA 3 
colloidal oatmeal, dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-580
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	3.36 g  in 168 g
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.168 g  in 168 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-580-06	168 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2020

Labeler - Renu Laboratories, Inc. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(76348-580)