MedPath

Gold Bond Ultimate Eczema Relief Hand

Gold-Bond-Eczema-Relief-Hand-Cream

Approved
Approval ID

0806e5eb-7143-4014-a3dd-a43df7f8f646

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 31, 2025

Manufacturers
FDA

Chattem, Inc.

DUNS: 003336013

Products 1

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

Colloidal oatmeal

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code41167-0663
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Colloidal oatmeal
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 31, 2025
FDA Product Classification

INGREDIENTS (30)

PROPANEDIOLInactive
Code: 5965N8W85T
Classification: IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)Inactive
Code: 86FQE96TZ4
Classification: IACT
CERAMIDE 2Inactive
Code: C04977SRJ5
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
OATMEALActive
Quantity: 0.02 g in 1 g
Code: 8PI54V663Y
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
JOJOBA OIL, RANDOMIZEDInactive
Code: 7F0EV20QYL
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9Y
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
OATInactive
Code: Z6J799EAJK
Classification: IACT
GINGERInactive
Code: C5529G5JPQ
Classification: IACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERSInactive
Code: 137SL7IL0Y
Classification: IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)Inactive
Code: UDR641JW8W
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
MAGNESIUM ASCORBYL PHOSPHATEInactive
Code: 0R822556M5
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
TRIBEHENINInactive
Code: 8OC9U7TQZ0
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
EDETIC ACIDInactive
Code: 9G34HU7RV0
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
PALMITOYL HEXAPEPTIDE-12Inactive
Code: HO4ZT5S86C
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/31/2025

PRINCIPAL DISPLAY PANEL

GOLD BOND®
ULTIMATE
2 % colloidal oatmeal
eczema relief
hand cream
Net wt 3 oz (85 g)

![GOLD BOND® ULTIMATE 2 % colloidal oatmeal eczema relief hand cream Net wt 3 oz (85 g) ](/dailymed/image.cfm?name=gold-bond-eczema-relief-hand- cream-01.jpg&id=874711)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/31/2025

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

  • Eczema

  • Rashes

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/31/2025

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/31/2025

Active i****ngredient

Colloidal oatmeal 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/31/2025

Purpose

Skin protectant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/31/2025

Warnings

For external use only

When using this produc****t

  • avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens

  • symptoms persist for 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 immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/31/2025

Directions

  • apply to affected areas of skin as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/31/2025

Inactive ingredients

water, glycerin, dimethicone, petrolatum, propanediol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, glyceryl stearate, butyrospermum parkii (shea) butter extract, isohexadecane, avena sativa (oat) kernel extract, bisabolol, zingiber officinale (ginger) root extract, C10-30 cholesterol/lanosterol esters, ceramide NG, hydrolyzed jojoba esters, tocopheryl acetate, magnesium ascorbyl, phosphate, panthenol, ethylhexylglycerin, C12-C15 alkyl benzoate, tribehenin, potassium hydroxide, EDTA, phenoxyethanol, PEG-10 phytosterol, methylparaben, polysorbate 60, palmitoyl hexapeptide-12 (309-123)

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Gold Bond Ultimate Eczema Relief Hand - FDA Drug Approval Details