MedPath

Diabetic Advanced Healing Cream

Diabetic Advanced Healing Cream

Approved
Approval ID

46996845-9398-41d8-bf99-79f6a29bec28

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 30, 2025

Manufacturers
FDA

Neoteric Cosmetics, Inc.

DUNS: 790615181

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Dimethicone

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62673-161
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dimethicone
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2025
FDA Product Classification

INGREDIENTS (21)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
CYCLOMETHICONEInactive
Code: NMQ347994Z
Classification: IACT
SODIUM PYRROLIDONE CARBOXYLATEInactive
Code: 469OTG57A2
Classification: IACT
EUCALYPTUS GLOBULUS LEAFInactive
Code: S546YLW6E6
Classification: IACT
MYRISTYL MYRISTATEInactive
Code: 4042ZC00DY
Classification: IACT
TRIOLEINInactive
Code: O05EC62663
Classification: IACT
HYDROXYETHYL UREAInactive
Code: MBQ7DDQ7AR
Classification: IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)Inactive
Code: 59TL3WG5CO
Classification: IACT
STYRAX BENZOIN GUMInactive
Code: FE663Z8IRO
Classification: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BA
Classification: IACT
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW)Inactive
Code: H58HX2GWJ5
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
DIMETHICONEActive
Quantity: 0.01 mg in 1 g
Code: 92RU3N3Y1O
Classification: ACTIB
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 809Y72KV36
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/30/2025

NEOTERIC

Diabetic ®
SKIN CARE

CLINICALLY PROVEN TREATMENT FOR DIABETIC SKIN

OXYGENATED

HEALING CREAM

with TriOxygen c

Oxygen-infused lipids that help improve circulation to support healing.

MEDICATED DAILY THERAPY

For Severely Dry Diabetic Skin

+ Protects

+ Deeply Moisturizes

+ Repairs

1% Dimethicone

NET WT 4OZ | 113G

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/30/2025

Uses

  • Temporarily protects and helps relieve chapped or cracked skin
  • Helps protect from the dry effects of wind and cold weather

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/30/2025

Distributed by

Neoteric Cosmetics, Inc.

New York, NY 10003

Made in USA

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/30/2025

Active ingredient

Dimethicone 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/30/2025

Purpose

Skin protection

WARNINGS SECTION

LOINC: 34071-1Updated: 4/30/2025

Warnings

*For external use only.

  • Do not get into eyes
  • Do not use on deep or puncture wounds
  • Do not use on serious burns

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/30/2025

Directions

  • Apply as needed or directed by a physician

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/30/2025

Inactive ingredients

Aqua/Water/Eau, Oxidized Corn Oil*, Liquid Paraffin, Sodium Hydroxide, Triolein, Isopropyl Palmitate, Hydroxyethyl Urea, Tocopheryl Acetate, Eucalyptus Globulus Leaf Extract, Styrax Benzoin Gum Extract, Cyclopentasiloxane, Sodium PCA, Sodium Lactate, Myristyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Cyclohexasiloxane, Hydrogenated Styrene/Isoprene Copolymer, Phenoxyethanol, Ethylhexylglycerin, Fragrance/Parfum (*Oxygenated Corn Oil)

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 4/30/2025

Questions?

Call1-877-531-0268

email info@neotericdiabetic.com

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Diabetic Advanced Healing Cream - FDA Drug Approval Details