GOLD BOND EXTRA STRENGTH- menthol lotion

Gold Bond Extra Strength by

Drug Labeling and Warnings

Gold Bond Extra Strength 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 – Extra Strength Gold Bond Body Lotion

Active ingredients

Menthol 0.5%

Purpose

Anti-itch

Uses

temporarily relieves the pain and itching associated with:

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

Warnings

For external use only

Do not use on

• deep or puncture wounds
  
• animal 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 persist for more than 7 days or clear up and occur again within a few days
  
• 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 right away.

Directions

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

children under 2 years: ask a doctor

Inactive ingredients

water, dimethicone, glycerin, petrolatum, aloe barbadensis leaf juice, cetyl alcohol, stearyl alcohol, propylene glycol, stearamidopropyl PG-dimonium chloride phosphate, distearyldimonium chloride, cetearyl alcohol, polysorbate 60, steareth-21, steareth-2, tocopheryl acetate, EDTA, imidazolidinyl urea, methylparaben, potassium hydroxide, fragrance

PRINCIPAL DISPLAY PANEL

GOLD BOND® 
EXTRA STRENGTH
BODY LOTION
Triple Action Relief
For Extra Dry & Itchy Skin
Net wt 14 oz (396 g)

INGREDIENTS AND APPEARANCE

GOLD BOND EXTRA STRENGTH 
menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0641
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IMIDUREA (UNII: M629807ATL)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0641-2	396 g in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2016
2	NDC: 41167-0641-4	476 g in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	03/11/2016

Labeler - Chattem, Inc. (003336013)