Gold Bond Pain Relieving Foot Cream

Gold Bond Pain Relieving Foot by

Drug Labeling and Warnings

Gold Bond Pain Relieving Foot by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GOLD BOND PAIN RELIEVING FOOT- menthol cream 
Chattem, Inc.

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.

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Gold Bond Pain Relieving Foot Cream

Drug Facts

Active ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

temporary relieves minor foot and ankle aches and pains associated with

• arthritis
  
• muscle aches
  
• strains
  
• sprains
  
• muscle and joint pain

Warnings

For external use only

When using this product

• use only as directed
  
• do not bandage tightly or use with a heating pad
  
• avoid contact with eyes and mucous membranes
  
• do not apply to wounds or damaged skin
  
• if severe burning sensation occurs, discontinue use immediately
  
• do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

• condition worsens
  
• redness is present
  
• symptoms persist for more than 7 days or clear up and occur again within a few days
  
• irritation or burning develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

adults and children 12 years or age and older:

• apply generously to affected area not more than 3 to 4 times daily
  
• massage gently for 30 seconds or until fully absorbed
  
• wash hands thoroughly after use

children under 12 years: ask a doctor

Inactive ingredients

water, hydroxyethyl urea, cetearyl alcohol, cetyl alcohol, polysorbate 60, cetyl ester, stearyl alcohol, ethoxydiglycol, SD alcohol 40 (2%), distearyldimonium chloride, steareth-21, steareth-2, stearamidopropyl PG-dimonium chloride phosphate, benzyl alcohol, aloe barbadensis leaf juice, fragrance, propylene glycol, disodium EDTA, diisopropyl adipate, di-PEG-2 soyamine/IPDI copolymer, triethanolamine, tocopheryl acetate, capsaicin (245-245)

PRINCIPAL DISPLAY PANEL

GOLD BOND® 
Pain Relieving
Foot Cream
Menthol 16%
Net wt 4 oz (113 g)

GOLD BOND PAIN RELIEVING FOOT 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETYL ESTERS WAX (UNII: D072FFP9GU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPSAICIN (UNII: S07O44R1ZM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0174-4	1 in 1 CARTON	12/01/2008	11/01/2019
1		113 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	12/01/2008	11/01/2019

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-0174) , LABEL(41167-0174) , MANUFACTURE(41167-0174) , PACK(41167-0174)

Revised: 12/2008

Document Id: 9b58b9b6-1728-47f6-8617-7f0093b91a71

34390-5

Set id: 1d625115-66bc-41e5-9d29-67cc526aa830

Version: 2

Effective Time: 20081201

 

Chattem, Inc.