TRONOLANE- pramoxine hcl cream 
New Genesis/Monticello Drug LLC

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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Tronolane ®

Drug Facts

Active ingredientsPurposes
Pramoxine hydrochloride 1%Local anesthetic
Zinc oxide 5%Astringent   

Uses

  • temporarily relieves pain, itching, burning and soreness associated with hemorrhoids.

Warnings

For external use only. Certain persons can develop allergic reactions to ingredients in this product. If symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

If pregnant or breast-feeding, ask a health professional before use.

When using this product, do not exceed the recommended daily dose, unless directed by a doctor. Do not put this product in the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if:

  • bleeding occurs
  • condition worsens or does not improve within 7 days

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

Directions

  • Adults and children 12 years of age and older: Apply externally to the affected area up to 5 times daily.
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or cleanse by patting or blotting with an appropriate cleansing pad.
  • Gently dry by patting or blotting with toilet tissue before application of this product.
  • To use applicator: Remove cap from tube and attach applicator. Gently squeeze tube to apply: do not insert applicator into rectum. Thoroughly cleanse applicator after use.
  • Children under 12 years of age: consult a doctor.

Other information

  • For your protection, do not use if glue end carton or seal under cap is broken.

Inactive ingredients

beeswax, cetyl alcohol, cetyl esthers wax, glycerin, methylparaben, propylparaben, sodium lauryl sulfate, USP water

Distributed by : New Genesis / Monticello Drug LLC
Jacksonville, FL 32207

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

NDC 11868-390-48

Tronolane ®
Anesthetic Cream for Hemorrhoids

DUAL-ACTION
FORMULA

Rapid Relief
of Pain & Itching

Odor-free • Non-greasy • Non-staining

1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
TRONOLANE 
pramoxine hcl cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11868-390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11868-390-481 in 1 CARTON12/04/2011
1NDC:11868-390-2828 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11868-390-591 in 1 CARTON03/04/2015
2NDC:11868-390-5857 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01612/04/201101/01/2023
Labeler - New Genesis/Monticello Drug LLC (079396165)
Registrant - ULTRAtab Laboratories, Inc. (151051757)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(11868-390)

Revised: 1/2023
Document Id: f18b44ea-5d2e-6043-e053-2a95a90afbac
Set id: 0d5ba4f1-1178-490d-8524-143d0aa2f0ef
Version: 7
Effective Time: 20230105
 
New Genesis/Monticello Drug LLC