Your browser does not support JavaScript! GOLD BOND ULTIMATE DIABETICS (DIMETHICONE AND WHITE PETROLATUM) CREAM [CHATTEM, INC.]
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GOLD BOND ULTIMATE DIABETICS (dimethicone and white petrolatum) cream
[Chattem, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts – Gold Bond Ultimate Diabetics’ Dry Skin Relief Foot Cream

Active ingredients

Dimethicone 3%
White petrolatum 30%

Purpose

Skin protectant

Uses

  • helps relieve, prevent and temporarily protect chafed, chapped, cracked or windburned skin
  • temporarily protects minor burns, cuts, and scrapes
  • helps protect from the drying effects of wind and cold weather

Warnings

For external use only

When using this product

  • 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

Do not use on

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • apply generously to affected area as needed

Inactive ingredients

water, glycerin, glyceryl stearate, distearyldimonium chloride, aloe barbadensis leaf juice, polyethylene, stearyl alcohol, cetearyl alcohol, methyl gluceth-20, behentrimonium methosulfate, steareth-21, steareth-2, allantoin, cocodimonium hydroxypropyl hydrolyzed rice protein, cetyl alcohol, tocopheryl acetate, butyrospermum parkii (shea) butter extract, PEG-10 rapeseed sterol, polysorbate 60, ceramide 2, hydrolyzed collagen, stearamidopropyl PG-dimonium chloride phosphate, jojoba esters, DMDM hydantoin, magnesium ascorbyl phosphate, butylenes glycol, methylparaben, palmitoyl oligopeptide, propylene glycol, hydrolyzed jojoba esters, propylparaben, EDTA, potassium hydroxide, tribehenin, C12-15 alkyl benzoate, retinyl palmitate (309-007)

PRINCIPAL DISPLAY PANEL

Gold Bond Ultimate
Skin Protectant Foot Cream
diabetics’
Dry Skin Relief
Net wt 3.4 oz (96 g)

Gold Bond Ultimate
Skin Protectant Foot Cream
diabetics’ 
Dry Skin Relief
Net wt 3.4 oz (96 g)

GOLD BOND ULTIMATE DIABETICS 
dimethicone and white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-0540
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.03 g  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM0.3 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
GLYCERYL MONOSTEARATE 
DISTEARYLDIMONIUM CHLORIDE 
ALOE VERA LEAF 
STEARYL ALCOHOL 
CETOSTEARYL ALCOHOL 
METHYL GLUCETH-20 
BEHENTRIMONIUM METHOSULFATE 
STEARETH-21 
STEARETH-2 
ALLANTOIN 
CETYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
SHEA BUTTER 
PEG-10 RAPESEED STEROL 
POLYSORBATE 60 
CERAMIDE 2 
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE 
DMDM HYDANTOIN 
MAGNESIUM ASCORBYL PHOSPHATE 
METHYLPARABEN 
PALMITOYL OLIGOPEPTIDE 
PROPYLENE GLYCOL 
HYDROLYZED JOJOBA ESTERS (ACID FORM) 
PROPYLPARABEN 
EDETIC ACID 
POTASSIUM HYDROXIDE 
TRIBEHENIN 
ALKYL (C12-15) BENZOATE 
VITAMIN A PALMITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0540-01 in 1 CARTON
196 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34702/03/1998
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 2830410721ANALYSIS(41167-0540), LABEL(41167-0540), MANUFACTURE(41167-0540), PACK(41167-0540), RECOVERY(41167-0540), RELABEL(41167-0540), REPACK(41167-0540)

Revised: 4/2013
 
Chattem, Inc.

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