Drug Facts

Active ingredients

Menthol 1%

Pramoxine hydrochloride 1%

Purpose

Anti-itch, Pain relief

Uses

for temporary relief of pain and itching associated with:

minor skin irritations
minor cuts
minor burns
minor sunburns
rashes due to poison ivy, poison oak or poison sumac
scrapes
insect bites

Warnings

For external use only

Do not use on

deep or puncture wounds
animals 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 last more than 7 days or clear up and occur again within a few days
if 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 immediately.

Directions

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

children under 2 years: consult a doctor

Inactive ingredients

water, petrolatum, propylene glycol, stearyl alcohol, aloe barbadensis leaf juice, triethanolamine, sodium acrylates copolymer, steareth-21, mineral oil, steareth-2, tocopheryl acetate, thymol, eucalyptol, methyl salicylate, PPG-1 trideceth-6,diazolidinyl urea, disodium EDTA, , iodopropynyl butylcarbamate

PRINCIPAL DISPLAY PANEL

RAPID RELIEF GOLD BOND®
Net wt 1 oz (28 g)
ANTI-ITCH CREAM

GOLD BOND ANTI ITCH
menthol and pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0501
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
STEARETH-21 (UNII: 53J3F32P58)
MINERAL OIL (UNII: T5L8T28FGP)
STEARETH-2 (UNII: V56DFE46J5)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
THYMOL (UNII: 3J50XA376E)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0501-0	1 in 1 CARTON	04/01/1996
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:41167-0501-1	1 in 1 CARTON	04/01/1996	02/27/2019
2		35 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:41167-0501-2	1 in 1 CARTON	04/01/1996	02/28/2019
3		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/01/1996

Labeler - Chattem, Inc. (003336013)

Gold Bond Anti Itch