PEDIADERMICS ECZEMA 2- hydrocortisone spray 
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.

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PEDIADERMICS ECZEMA 2

pediadermics Eczema 2 flare control spray

Active Ingredients:

Hydrocortisone 1%

Purpose

Anti-itch

Uses:

For the temporary relief of minor skin irritations, inflammation and rashes due to eczema

Warnings For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children

Directions

For best results follow the rule of "2s" ...

Inactive Ingredients

1, 2 Hexanediol, Avena Sativa (Oat) Kernel Extract, Carbomer, Ceramide AP, Ceramide EOP, Ceramide NP, Cholesterol, Citric Acid, Deionized Water, Glycerin (Vegetal), Maltodextrin, UMF-20 Manuka Honey (20%), Ophiopogon Japonicus (Dwarf Lilyturf) Root Extract, Phytosphingosine, Sodium Citrate, Sodium Hyaluronate, Sodium Lauroyl Lactylate, Sorbitol, Xanthan Gum

Manufactured for Pediadermics LLC

Bethlehem PA 18018

www.pediadermics.com

BOTTLE ARTWORK

BOTTLE ART

PEDIADERMICS ECZEMA 2 
hydrocortisone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-585
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1.12 g  in 112 g
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
OAT (UNII: Z6J799EAJK)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HONEY (UNII: Y9H1V576FH)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76348-585-04112 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/18/2022
Labeler - RENU LABORATORIES, INC. (945739449)
Establishment
NameAddressID/FEIBusiness Operations
RENU LABORATORIES, INC.945739449manufacture(76348-585)

Revised: 3/2022
Document Id: da840bf6-ed64-bafc-e053-2a95a90a92d5
Set id: da840bf6-ed65-bafc-e053-2a95a90a92d5
Version: 1
Effective Time: 20220318
 
RENU LABORATORIES, INC.