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FDA Approval

Gold Bond Ultimate Eczema Relief Hand

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Chattem, Inc.
DUNS: 003336013
Effective Date
May 31, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Colloidal oatmeal(0.02 g in 1 g)

Products1

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

Gold Bond Ultimate Eczema Relief Hand

Product Details

NDC Product Code
41167-0663
Application Number
M016
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
May 31, 2025
PROPANEDIOLInactive
Code: 5965N8W85TClass: IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)Inactive
Code: 86FQE96TZ4Class: IACT
CERAMIDE 2Inactive
Code: C04977SRJ5Class: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3PClass: IACT
Code: 8PI54V663YClass: ACTIBQuantity: 0.02 g in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
JOJOBA OIL, RANDOMIZEDInactive
Code: 7F0EV20QYLClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0XClass: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4Class: IACT
BUTYROSPERMUM PARKII (SHEA) BUTTERInactive
Code: K49155WL9YClass: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1EClass: IACT
OATInactive
Code: Z6J799EAJKClass: IACT
GINGERInactive
Code: C5529G5JPQClass: IACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERSInactive
Code: 137SL7IL0YClass: IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)Inactive
Code: UDR641JW8WClass: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
MAGNESIUM ASCORBYL PHOSPHATEInactive
Code: 0R822556M5Class: IACT
PANTHENOLInactive
Code: WV9CM0O67ZClass: IACT
ALKYL (C12-15) BENZOATEInactive
Code: A9EJ3J61HQClass: IACT
TRIBEHENINInactive
Code: 8OC9U7TQZ0Class: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
EDETIC ACIDInactive
Code: 9G34HU7RV0Class: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3TClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
PALMITOYL HEXAPEPTIDE-12Inactive
Code: HO4ZT5S86CClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Uses

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

  • Eczema

  • Rashes

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply to affected areas of skin as needed

WARNINGS SECTION

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.


OTC - ACTIVE INGREDIENT SECTION

Active i****ngredient

Colloidal oatmeal 2%

OTC - PURPOSE SECTION

Purpose

Skin protectant


SPL UNCLASSIFIED SECTION

Drug Facts

INACTIVE INGREDIENT SECTION

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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