TUCKS  FAST RELIEF- pramoxine hydrochloride spray 
Johnson & Johnson Consumer 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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Tucks Fast Relief Spray

Drug Facts

Active ingredient

Pramoxine HCL 1%

Purpose

Pain reliever

Use

  • temporary relieves these local symptoms associated with hemorrhoids:
    • pain
    • itching
    • discomfort

Warnings

For external use only

When using this product

  • do not use more than directed unless told to do so by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • allergic reaction occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 12 years of age and older: apply to the affected area up to 5 times daily
    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or a soft cloth before application
  • children under 12 years of age: ask a doctor

Other information

  • store at 20 to 25°C (68-77°F)

Inactive ingredients

aloe barbadensis leaf juice, denatonium benzoate, ethyl alcohol, polysorbate 20, t-butyl alcohol, tocopheryl acetate, water

Questions?

call toll-free 800-223-0182 or 215-273-8755 (collect)

Distributed by: Johnson & Johnson
Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418
©McNEIL-PPC, Inc. 2012

PRINCIPAL DISPLAY PANEL - 14.8 mL Bottle Label

NEW

USE AT HOME OR
ON=THE-GO

TUCKS®

FAST RELIEF SPRAY

HEMORRHOIDAL SPRAY

Relieves pain,
itching and burning

clean feeling spray

sprays
upside-down

BRAND USED
BY HOSPITALS

0.5 fl oz (14.8mL)

Principal Display Panel - 14.8 mL Bottle Label
TUCKS   FAST RELIEF
pramoxine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
ALCOHOL (UNII: 3K9958V90M)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-504-011 in 1 CARTON04/17/201207/15/2016
114.8 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34604/17/201207/15/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 7/2016
 
Johnson & Johnson Consumer Inc.