deflame

deflame
SPL v2
SPL
SPL Set ID 2628bd73-0ca9-497b-bcd9-088444cd62be
Route
topical
Published
Effective Date 2025-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
allantoin (5 mg)
Inactive Ingredients
water propylene glycol glycerin dimethyl sulfone strontium chloride hexahydrate dimethicone cetyl alcohol glyceryl monostearate propanediol glycyrrhizinate dipotassium polysorbate 20 laureth-4 arnica montana flower octyldodecyl xyloside butylene glycol hyaluronate sodium 1,2-hexanediol aceglutamide octyldodecanol peg-30 dipolyhydroxystearate (4000 mw) sorbitan tristearate phenoxyethanol benzyl alcohol caprylyl glycol potassium sorbate edetate disodium anhydrous sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-01

Purpose

Skin Protectant

Description

Drug Facts


Medication Information

Warnings

For external use only.

Uses
  • Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.
Purpose

Skin Protectant

Directions
  • Apply as needed.
Inactive Ingredients

Aqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Do Not Use On
  • deep or puncture wounds, animal bites, serious burns.
Active Ingredient

Allantoin 0.5%

Questions Or Comments?

Visit noonaesthetics.com or call Toll Free 1.833.666.6246

When Using This Product
  • avoid contact with eyes. In case of eye contact, flush with water.
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.
Principal Display Panel 50 Ml Tube Carton

noon

AESTHETICS

DeFlame

SKIN PROTECTANT

+ DERMSHIELD™

50 ml / 1.75 Fl. Oz. e


Structured Label Content

Warnings

For external use only.

Uses
  • Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.
Purpose

Skin Protectant

Directions
  • Apply as needed.
Inactive Ingredients

Aqua, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Polydimethylsiloxane, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Polysaccharide, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Do Not Use On (Do not use on)
  • deep or puncture wounds, animal bites, serious burns.
Active Ingredient

Allantoin 0.5%

Questions Or Comments? (Questions or comments?)

Visit noonaesthetics.com or call Toll Free 1.833.666.6246

When Using This Product (When using this product)
  • avoid contact with eyes. In case of eye contact, flush with water.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.
Principal Display Panel 50 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton)

noon

AESTHETICS

DeFlame

SKIN PROTECTANT

+ DERMSHIELD™

50 ml / 1.75 Fl. Oz. e


Advanced Ingredient Data


Raw Label Data

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