NDC Code(s) : 41167-0610-2, 41167-0610-8, 41167-0640-2, 41167-0640-8
Packager : Chattem, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Gold Bond Original StrengthDimethicone and Menthol LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41167-0610
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE0.05 g in 1 g
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL0.0015 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PETROLATUM(UNII: 4T6H12BN9U)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE(UNII: W6000VEI5Y)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
STEARETH-2(UNII: V56DFE46J5)
POLYSORBATE 60(UNII: CAL22UVI4M)
STEARETH-21(UNII: 53J3F32P58)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
EDETATE DISODIUM(UNII: 7FLD91C86K)
IMIDUREA(UNII: M629807ATL)
METHYLPARABEN(UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41167-0610-2396 g in 1 BOTTLE Type 0: Not a Combination Product02/03/1998
2NDC:41167-0610-8226 g in 1 BOTTLE Type 0: Not a Combination Product02/03/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 02/03/1998 06/24/2018
Gold Bond Extra StrengthDimethicone and Menthol LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:41167-0640
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE0.05 g in 1 g
MENTHOL(UNII: L7T10EIP3A)
(MENTHOL - UNII:L7T10EIP3A) 		MENTHOL0.005 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PETROLATUM(UNII: 4T6H12BN9U)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE(UNII: W6000VEI5Y)
DISTEARYLDIMONIUM CHLORIDE(UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
STEARETH-21(UNII: 53J3F32P58)
STEARETH-2(UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE, D-(UNII: A7E6112E4N)
EDETATE DISODIUM(UNII: 7FLD91C86K)
IMIDUREA(UNII: M629807ATL)
METHYLPARABEN(UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:41167-0640-2396 g in 1 BOTTLE Type 0: Not a Combination Product02/03/1998
2NDC:41167-0640-8226 g in 1 BOTTLE Type 0: Not a Combination Product02/03/1998
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 02/03/1998 08/10/2018

PRINCIPAL DISPLAY PANEL

ORIGINAL STRENGTH GOLD BOND® BODY LOTION
MEDICATED HEALING SINCE 1908®
TRIPLE ACTION RELIEF FOR DRY & ITCHY SKIN
14 oz (396 g)

PRINCIPAL DISPLAY PANEL ORIGINAL STRENGTH GOLD BOND BODY LOTION TRIPLE ACTION RELIEF FOR DRY & ITCHY SKIN 14 oz (396 g)

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH GOLD BOND® BODY LOTION
MEDICATED HEALING SINCE 1908®
TRIPLE ACTION RELIEF FOR EXTRA DRY & ITCHY SKIN
14 oz (396 g)

PRINCIPAL DISPLAY PANEL EXTRA STRENGTH GOLD BOND BODY LOTION TRIPLE ACTION RELIEF FOR EXTRA DRY & ITCHY SKIN 14 oz (396 g)