GOLD BOND MEDICATED ANTI-ITCH- pramoxine hydrochloride, menthol lotion

Gold Bond Medicated Anti-Itch by

Drug Labeling and Warnings

Gold Bond Medicated Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Gold Bond Co LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active ingredients

Menthol 0.5%
Pramoxine hydrochloride 1%

Purpose

Anti-itch
Anti-itch

Use

for temporary relief of pain and itching associated with:

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

Warnings

For external use only

When using this product

■ 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 immediately.

Directions

adults and children 2 years of age and older: apply freely to affected area not more than 3 to 4 times daily

children under 2 years of age: consult a doctor

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

GOLD BOND
ANTI-ITCH LOTION
Net wt 5.5 oz (155 g)

INGREDIENTS AND APPEARANCE

GOLD BOND MEDICATED ANTI-ITCH 
pramoxine hydrochloride, menthol lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84714-0507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
PETROLATUM (UNII: 4T6H12BN9U)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
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)
OAT (UNII: Z6J799EAJK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84714-0507-0	155 g in 1 BOTTLE; Type 0: Not a Combination Product	04/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/26/2016

Labeler - Gold Bond Co LLC (119184861)