GOLD BOND ANTI ITCH- menthol and pramoxine hydrochloride cream

Gold Bond Anti Itch by

Drug Labeling and Warnings

Gold Bond Anti Itch by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

GOLD BOND ANTI ITCH 
menthol and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.01 g  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	0.01 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PETROLATUM (UNII: 4T6H12BN9U)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARETH-21 (UNII: 53J3F32P58)
MINERAL OIL (UNII: T5L8T28FGP)
STEARETH-2 (UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
THYMOL (UNII: 3J50XA376E)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0501-0	1 in 1 CARTON	04/01/1996
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41167-0501-1	1 in 1 CARTON	04/01/1996	02/27/2019
2		35 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 41167-0501-2	1 in 1 CARTON	04/01/1996
3		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	04/01/1996

Labeler - Chattem, Inc. (003336013)