GOLD BOND INTENSIVE HEALING ANTI ITCH SKIN PROTECTANT- pramoxine hydrochloride cream
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Gold Bond Intensive Healing Anti-Itch Cream

Drug Facts

Active ingredient

Pramoxine hydrochloride 1%

Purposes

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
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 last for 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, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-21, steareth-2, propylene glycol, chamomilla recutita (matricaria) flower extract, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, methyl gluceth-20, tocopheryl acetate, magnesium ascorbyl phosphate, panthenol, retinyl palmitate, EDTA, potassium hydroxide, diazolidinyl urea, methylparaben, propylparaben, hydrolyzed jojoba esters, glyceryl stearate

KEEP CARTON AS IT CONTAINS IMPORTANT PRODUCT INFORMATION www.goldbond.com

Principal Display Panel

GOLD BOND®
INTENSIVE HEALING
Net wt 1 oz (28 g)

ANTI-ITCH CREAM
1% PRAMOXINE HYDROCHLORIDE

GOLD BOND®
INTENSIVE HEALING
Net wt 1 oz (28 g)

ANTI-ITCH CREAM
1% PRAMOXINE HYDROCHLORIDE

GOLD BOND INTENSIVE HEALING ANTI ITCH SKIN PROTECTANT
pramoxine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0511
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CHAMOMILE (UNII: FGL3685T2X)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: W6000VEI5Y)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
PANTHENOL (UNII: WV9CM0O67Z)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETIC ACID (UNII: 9G34HU7RV0)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0511-0	1 in 1 CARTON	01/26/2018	11/30/2019
1		28 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 not final	part348	01/26/2018	11/30/2019

Labeler - Chattem, Inc. (003336013)

Revised: 1/2023

Document Id: 3d17d563-8a22-461b-9cc1-54850f8de403

Set id: 4d698df6-20bc-4315-aca4-f45f740dcf39

Version: 3

Effective Time: 20230104

Chattem, Inc.