Pediadermics Eczema 2

Pediadermics Eczema 2
SPL v3
SPL
SPL Set ID da840bf6-ed65-bafc-e053-2a95a90a92d5
Route
TOPICAL
Published
Effective Date 2022-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1.12 g)
Inactive Ingredients
1,2-hexanediol Sorbitol Solution 70% Oat Sodium Citrate Honey Phytosphingosine Hyaluronate Sodium Citric Acid Monohydrate Maltodextrin Cholesterol Sodium Lauroyl Lactylate Phenoxyethanol Ethylhexylglycerin Carbomer Homopolymer, Unspecified Type Xanthan Gum Water Ceramide 1 Ceramide Np Ceramide Ap Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-18

Description

pediadermics Eczema 2 flare control spray


Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Uses:

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

Dosage and 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
Description

pediadermics Eczema 2 flare control spray

Section 43683-2

Dosage and Administration - NO Major Changes at all

Section 50565-1

Keep out of reach of children

  • If swallowed get medical help or contact a Poison Control Center right away
Section 50566-9

Stop use and ask a doctor if

  • Condition worsens or irritation occurs
  • Symptoms last more than 2 weeks
Section 50567-7

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
Section 51727-6

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

Section 51945-4

BOTTLE ARTWORK

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredients:

Hydrocortisone 1%

Section 69718-5

pediadermics Eczema 2 flare control spray


Structured Label Content

Indications and Usage (34067-9)

Uses:

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

Dosage and Administration (34068-7)

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
Warnings and Precautions (34071-1)

Warnings For external use only

Section 43683-2 (43683-2)

Dosage and Administration - NO Major Changes at all

Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens or irritation occurs
  • Symptoms last more than 2 weeks
Section 50567-7 (50567-7)

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
Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

BOTTLE ARTWORK

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredients:

Hydrocortisone 1%

Section 69718-5 (69718-5)

pediadermics Eczema 2 flare control spray


Advanced Ingredient Data


Raw Label Data

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