PEDIADERMICS ECZEMA 2- hydrocortisone spray

PEDIADERMICS ECZEMA 2 by

Drug Labeling and Warnings

PEDIADERMICS ECZEMA 2 by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

pediadermics Eczema 2 flare control spray

ACTIVE INGREDIENT

Active Ingredients:

Hydrocortisone 1%

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses:

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

WARNINGS

Warnings For external use only

WHEN USING

When using this product

• Avoid direct contact with eyes, mouth, genitals/anus
• Do not use for treatment of diaper rash without consulting a physician first

STOP USE

Stop use and ask a doctor if

• Condition worsens or irritation occurs
• Symptoms last more than 2 weeks

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 "2s" ...

• Consult a physician before using on children under "2" years of age
• Give the bottle at least "2" good shakes before using
• Hold the botle about "2" inches from the skin
• Dispense at least "2" full pump sprays onto areas of flaring (red, rough, itchy) skin
• Cover flaring areas of skin completely plus about "2" finger-widths onto normal skin
• Use "2" times a day for no more than "2" weeks straight.
• Go to a physician if rash persists for more than "2" weeks

INACTIVE INGREDIENT

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

STATEMENT OF IDENTITY

Manufactured for Pediadermics LLC

Bethlehem PA 18018

www.pediadermics.com

PRINCIPAL DISPLAY PANEL

BOTTLE ARTWORK

INGREDIENTS AND APPEARANCE

PEDIADERMICS ECZEMA 2 
hydrocortisone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-585
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1.12 g  in 112 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-585-04	112 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/18/2022

Labeler - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-585)