GOLD BOND INTENSIVE HEALING ANTI ITCH SKIN PROTECTANT- pramoxine hydrochloride cream

Gold Bond Intensive Healing Anti Itch Skin Protectant by

Drug Labeling and Warnings

Gold Bond Intensive Healing Anti Itch Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0511-0	1 in 1 CARTON	01/26/2018
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/26/2018

Labeler - Chattem, Inc. (003336013)