GOLD BOND ANTI ITCH- menthol, pramoxine hcl, and dimethicone lotion

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., Chattem Plant 2. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Dimethicone 5%
Menthol 0.5%

Pramoxine hydrochloride 1%

Purpose

Skin protectant, Anti-itch, Pain relief

Uses

temporary relieves itching associated with

• minor burns
  
• minor skin irritation
  
• sunburn
  
• eczema or psoriasis
  
• rashes due to poison ivy, oak or sumac
  
• temporarily protects and helps relieve chapped or cracked skin

Warnings

For external use only

Do not use on

• deep or puncture wounds
  
• animals bites
  
• serious burns

When using this product

• avoid contact with the eyes

Stop use and ask a doctor if

• condition worsens
  
• redness, irritation, swelling or pain persists or increases
  
• 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 immediately.

Directions

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

children under 2 years: consult a doctor

Inactive ingredients

water, glycerin, cetyl alcohol, petrolatum, distearyldimonium chloride, stearyl alcohol, aloe barbadensis leaf juice, glyceryl stearate, cetearyl alcohol, behentrimonium methosulfate, steareth-21, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, diazolidinyl urea, butylenes glycol, tocopheryl acetate, potassium hydroxide, methylparaban, panthenol, ethoxydiglycol, EDTA, propylparaban, avena sativa (oat) kernel extract (309-026)

PRINCIPAL DISPLAY PANEL

GOLD BOND® 
Healing Medicated
Since 1908
Intensive Relief
ANTI-ITCH LOTION
Net wt 5.5 oz (155 g)

INGREDIENTS AND APPEARANCE

GOLD BOND ANTI ITCH 
menthol, pramoxine hcl, and dimethicone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0506
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.005 g  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	0.01 g  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
STEARETH-21 (UNII: 53J3F32P58)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PANTHENOL (UNII: WV9CM0O67Z)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
EDETIC ACID (UNII: 9G34HU7RV0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
OAT (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0506-0	155 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/01/2008

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	12/01/2008

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 2		830410721	ANALYSIS(41167-0506) , LABEL(41167-0506) , MANUFACTURE(41167-0506) , PACK(41167-0506)