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Gold Bond Anti Itch by Chattem, Inc.

Dosage form: cream
Ingredients: MENTHOL 0.01g in 1g, PRAMOXINE HYDROCHLORIDE 0.01g in 1g
Labeler: Chattem, Inc.
NDC Code: 41167-0501

Disclaimer: 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.

Gold Bond Anti Itch

Drug Facts

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Anti-itch, Pain relief

Uses

for temporary relief of pain and itching associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • minor sunburns
  • rashes due to poison ivy, poison oak or poison sumac
  • scrapes
  • insect bites

Warnings

For external use only

Do not use on
  • deep or puncture wounds
  • animals bites
  • serious burns
  • large areas of the body

When using this product
  • do not get into eyes or nose
  • not for prolonged use

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
  • if redness, irritation, swelling or pain persists or increases

Keep out of reach of children.

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

Directions

adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

children under 2 years: consult a doctor

Inactive ingredients

water, propylene glycol, petrolatum, stearyl alcohol, aloe barbadensis leaf juice, sodium acrylates copolymer, steareth-21, mineral oil, steareth-2, tocopheryl acetate, thymol, eucalyptol, methyl salicylate, PPG-1 trideceth-6,diazolidinyl urea, disodium EDTA, triethanolamine, iodopropynyl butylcarbamate (240-022)

PRINCIPAL DISPLAY PANEL

ORIGINAL FORMULA GOLD BOND® MAXIMUM RELIEF
Net wt 1 oz (28 g)
ANTI-ITCH CREAM

GOLD BOND ANTI ITCH 
menthol and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0501
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL0.01 g  in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
PETROLATUM 
STEARYL ALCOHOL 
ALOE VERA LEAF 
STEARETH-21 
MINERAL OIL 
STEARETH-2 
.ALPHA.-TOCOPHEROL ACETATE, D- 
THYMOL 
EUCALYPTOL 
METHYL SALICYLATE 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage Description
1NDC:41167-0501-01 TUBE (1 TUBE) in 1 CARTON
128 g in 1 TUBE
2NDC:41167-0501-11 TUBE (1 TUBE) in 1 CARTON
235 g in 1 TUBE
3NDC:41167-0501-21 TUBE (1 TUBE) in 1 CARTON
356 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/01/1996
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIOperations
Chattem Plant 1003336013ANALYSIS
Establishment
NameAddressID/FEIOperations
Chattem Plant 2830410721LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Revised: 07/2011
 
Chattem, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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