TRONOLANE- pramoxine hcl cream

Tronolane by

Drug Labeling and Warnings

Tronolane by is a Otc medication manufactured, distributed, or labeled by New Genesis/Monticello Drug LLC, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

TRONOLANE 
pramoxine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11868-390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11868-390-48	1 in 1 CARTON	12/04/2011
1	NDC: 11868-390-28	28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11868-390-59	1 in 1 CARTON	03/04/2015
2	NDC: 11868-390-58	57 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 final	part347	12/04/2011

Labeler - New Genesis/Monticello Drug LLC (079396165)

Registrant - ULTRAtab Laboratories, Inc. (151051757)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(11868-390)