GOLD BOND MEDICATED PAIN AND ITCH RELIEF- lidocaine hydrochloride cream

Gold Bond Medicated Pain and Itch Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Gold Bond® Medicated
Pain & Itch Relief Cream with Lidocaine

Drug Facts

Active ingredient

Lidocaine HCl 4%

Purpose

Topical anesthetic

Use

for temporary relief of the pain and itching associated with:

• minor burns
  
• sunburn
  
• minor cuts
  
• scrapes
  
• insect bites
  
• minor skin irritations

Warnings

For external use only

Do not use

• in large quantities, particularly over raw surfaces of blistered area
  
• on deep or puncture wounds

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
  
• 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

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 of age and older:

• apply a thin layer to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, methylparaben, SD alcohol 40 (15%), steareth-21, water (309-179)

Child resistant packaging. Close cap tightly between uses.

PRINCIPAL DISPLAY PANEL

GoldBond
Pain & Itch Relief Cream
Net Wt 1.75 oz (49g)

INGREDIENTS AND APPEARANCE

GOLD BOND MEDICATED PAIN AND ITCH RELIEF 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALCOHOL (UNII: 3K9958V90M)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0505-0	1 in 1 CARTON	01/15/2016
1		49 g in 1 BOTTLE, PLASTIC; 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	01/15/2016

Labeler - Chattem, Inc. (003336013)