Lidocaine HCI 3% Hydrocortisone Acetate 0.5% Cream Lidocaine HCI 3% Hydrocortisone Acetate 1.0% Cream Lidocaine HCI 3% Hydrocortisone Acetate 2.5% Gel

LIDOCAINE HCI HYDROCORTISONE ACETATE CREAM  - lidocaine hydrochloride and hydrocortisone acetate cream 
LIDOCAINE HCI HYDROCORTISONE ACETATE CREAM  - lidocaine hydrochloride and hydrocortisone acetate cream 
River's Edge Pharmaceuticals, LLC

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Lidocaine HCI 3% Hydrocortisone Acetate 0.5% Cream Lidocaine HCI 3% Hydrocortisone Acetate 1.0% Cream Lidocaine HCI 3% Hydrocortisone Acetate 2.5% Gel

DESCRIPTION:

Lidocaine is chemically designated as acetamide, 2-(diethylamino)- N-(2,6-
dimethylphenyl), and has the following structure: C14H22N20 Mol. wt. 234.34


Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,17-
dihydroxy-(11ß)-. It has the following structural formula: C23H3206 Mol. wt. 404.50

INGREDIENTS:

River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 0.5% Cream
contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg. Inactive ingredients include:
Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol, Hydrochloric Acid, Methyl Paraben, Mineral
Oil, Polysorbate 60, Propyl Paraben, Propylene Glycol, Purified Water, Sodium Hydroxide,
Sorbitan Stearate, Stearic Acid, Stearyl Alcohol and White Petrolatum.


River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 1% Cream
contains Lidocaine HCI 30 mg and Hydrocortisone Acetate 10 mg. Inactive ingredients
include: Aluminum Sulfate, Glycerin, Calcium Acetate, Carbomer Polymer, Cetyl Alcohol,
Citric Acid, Methylparaben, Mineral Oil, Petrolatum, Polycarbophil, Propylene Glycol,
Propylparaben, Purified Water, Sodium Citrate, Sodium Hydroxide, Sodium Lauryl Sulfate,
Sorbitan Stearate, Stearic Acid, Stearyl Alcohol, Trolamine and Urea.


River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 2.5% Gel
contains Lidocaine Hydrochloride 30 mg and Hydrocortisone Acetate 25 mg.
Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Carbomer, Cetyl Alcohol,
Citric Acid , Glycerin, Methylparaben, Mineral Oil, Petrolatum, Polycarbophil, Glyceryl
Monostearate SE, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate,
Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol and Urea.

MECHANISM OF ACTION:

Product releases lidocaine to stabilize the neuronal membrane by
inhibiting the ionic fluxes required for initiation and conduction of impulses, thereby effecting
local anesthetic action. Hydrocortisone acetate provides relief of inflammatory and pruritic
manifestations of corticosteroid responsive dermatoses.

PHARMACOKINETICS:


Lidocaine may be absorbed following topical administration to
mucous membranes, its rate and extent of absorption depending upon the specific site of
application, duration of exposure, concentration, and total dosage. In general, the rate of
absorption of local anesthetic agents following topical application occurs most rapidly after
intratracheal administration. Lidocaine is also well-absorbed from the gastrointestinal tract,
but little intact drug appears in the circulation because of biotransformation in the liver.


Lidocaine is metabolized rapidly by the liver, and metabolites and unchanged drug are
excreted by the kidneys. Biotransformation includes oxidative N-dealkylation, ring hydroxylation,
cleavage of the amide linkage, and conjugation. N-dealkylation, a major pathway of
biotransformation, yields the metabolites monoethylglycinexylidide and glycinexylidide. The
pharmacological/toxicological actions of these metabolites are similar to, but less potent than,
those of lidocaine. Approximately 90% of lidocaine administered is excreted in the form of
various metabolites, and less than 10% is excreted unchanged. The primary metabolite in
urine is a conjugate of 4-hydroxy-2, 6-dimethylaniline.

The plasma binding of lidocaine is dependent on drug concentration, and the fraction bound
decreases with increasing concentration. At concentrations of 1 to 4 g of free base per mL,
60 to 80 percent of lidocaine is protein bound. Binding is also dependent on the plasma
concentration of the alpha-1-acid glycoprotein.

Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion.
Studies of lidocaine metabolism following intravenous bolus injections have shown that the
elimination half-life of this agent is typically 1.5 to 2 hours. Because of the rapid rate at which
lidocaine is metabolized, any condition that affects liver function may alter lidocaine kinetics.
The half-life may be prolonged two-fold or more in patients with liver dysfunction. Renal dysfunction
does not affect lidocaine kinetics but may increase the accumulation of metabolites.
Factors such as acidosis and the use of CNS stimulants and depressants affect the CNS levels
of lidocaine required to produce overt systemic effects. Objective adverse manifestations
become increasingly apparent with increasing venous plasma levels above 6 g free base
per mL. In the rhesus monkey arterial blood levels of 18-21 g/mL have been shown to be
threshold for convulsive activity.

The extent of percutaneous absorption of topical corticosteroids is determined by many
factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive
dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other
disease processes in the skin increase percutaneous absorption. Occlusive dressings
substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive
dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic
pathways similar to systemically administered corticosteroids. Corticosteroids are bound to
plasma protein in varying degrees. Corticosteroids are metabolized primarily in the liver and
are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites
are also excreted into the bile.

INDICATIONS:

Product is used for the anti-inflammatory and anesthetic relief of itching, pain,
soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions
of the anal area.

CONTRAINDICATIONS:

Product should not be used in patients with a history of sensitivity
to any of its ingredients or adverse reactions to lidocaine or amide anesthetics, which usually
do not cross-react with “caine” ester type anesthetics. If excessive irritation and significant
worsening occur, discontinue use and seek the advice of your physician. Product and topical
lidocaine should be used cautiously in those with impaired liver function, as well as the very
ill or very elderly and those with significant liver disease. Product should be used with caution
in patients receiving antiarrhythmic drugs of Class I since the adverse effects are additive
and generally synergistic. Product is contraindicated for tuberculous or fungal lesions or skin
vaccinia, varicella and acute herpes simplex. Topical corticosteroids are contraindicated in
those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS:

For external use only. Not for ophthalmic use. Product and used applicators
could harm small children if chewed or swallowed. Individual tubes are NOT child resistant.
Keep the product inside the child resistant blister until ready to use.

Keep product, cleansing wipes and applicators out of the reach of children.

Topical formulations of lidocaine may be absorbed to a greater extent through mucous membranes
and abaded, fissured or irritated skin than through intact skin. Product should not be
ingested or applied into the mouth, inside of the nose or in the eyes. Product should not be
used in the ears. Any situation where lidocaine penetrates beyond the tympanic membrane
into the middle ear is contraindicated because of ototoxicity associated with lidocaine observed
in animals when instilled in the middle ear. Product should not come into contact with
the eye or be applied into the eye because of the risk of severe eye irritation and the loss of
eye surface sensation which reduces protective reflexes and can lead to corneal irritation and possibly abrasion. If eye contact occurs, rinse out the eye immediately with saline or water
and protect the eye surface until sensation is restored.

PRECAUTIONS:

If irritation or sensitivity occurs or infection appears, discontinue use
and institute appropriate therapy. If extensive areas are treated, the possibility of systemic
absorption exists. Systemic absorption of topical steroids has produced reversible
hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s
syndrome, hyperglycemia, and glycosuria in some patients. Conditions which augment
systemic absorption include the application of the more potent steroids, use over large
surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients
receiving a large dose of potent topical steroids applied to a large surface area, or under
an occlusive dressing, should be evaluated periodically for evidence of HPA axis suppression.
If noted, an attempt should be made to withdraw the drug, to reduce the frequency of
application, or to substitute a less potent steroid. Recovery of the HPA axis function is
generally prompt and complete upon discontinuation of the drug. Infrequently, signs and
symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionately larger amounts of topical corticosteroids and thus
be more susceptible to systemic toxicity. If irritation develops, topical steroids should be
discontinued and appropriate therapy instituted. In the presence of dermatological infections,
the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable
response does not occur promptly, the corticosteroid should be discontinued until the
infection has been adequately controlled.

CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY:

Long-term animal
studies have not been performed to evaluate the carcinogenic potential or the effect on
fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed
negative results.

Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential of the
effect on fertility have not been conducted.

USE IN PREGNANCY:

Teratogenic Effects: Pregnancy Category C Reproduction studies
have been performed for lidocaine in rats at doses up to 6.6 times the human dose and
have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no
adequate and well-controlled studies in pregnant women. Animal reproduction studies are
not always predictive of human response. General consideration should be given to this fact
before administering lidocaine to women of childbearing potential, especially during early
pregnancy when maximum organogenesis takes place. Corticosteroids are generally teratogenic
in laboratory animals when administered systemically at relatively low dosage levels.
The more potent corticosteroids have been shown to be teratogenic after dermal application
in laboratory animals. There are no adequate and well controlled studies in pregnant women
on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids
should be used during pregnancy only if the potential benefit justifies the potential risk to
the fetus. Drugs of this class should not be used extensively on pregnant patients, in large
amounts, or for prolonged periods of time.

NURSING MOTHERS:

It is not known whether this drug is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when this drug is
administered to a nursing mother.

PEDIATRIC USE:

Safety and efficacy in children have not been established.

ADVERSE REACTIONS:

During or immediately or following application of product, there may
be transient stinging or burning from open areas of skin, or transient blanching (lightening),
or erythema (redness) of the skin.

DOSAGE AND ADMINISTRATION:

Apply product to the affected area(s) twice daily or as
directed by a physician. The cap should be removed from the tube and the applicator tip
firmly screwed onto the end of the tube and tightened. While holding the tube, squeeze the
tube to fill the applicator until a small amount of cream/gel shows and lubricate the end
of the tip with cream/gel. Gently insert the applicator tip with attached tube into anal area.
Continue squeezing the body of the tube as it is moved around the areas of discomfort,
and lastly, around and in the anal opening (if directed by physician).

Do not completely insert the applicator and tube into the anus or insert deep into the rectum.
Do not insert a loose applicator tip into the anus or rectum. Once application is completed,
the tube and applicator tip should be gently removed from the area and disposed. Note
that an adequate amount of product for an application to the anal and perianal area will be
applied through the applicator tip by gently squeezing the tube during application. Product
should not be used in excess of recommendations or for prolonged use in the anal canal.
If the condition does not respond to repeated courses of product or should worsen,
discontinue use and seek the advice of your physician.

HOW SUPPLIED:

River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 0.5% Cream contains
14 1/4 oz. (7 g) Tubes and Applicators.
NDC 68032-111-01.

River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 0.5% Cream KIT contains
20 Single-Use 1/4 oz. (7g) Tubes, Applicators and Cleansing Wipes.
NDC 68032-124-20.

River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 1% Cream KIT contains
20 Single-Use 1/4 oz. (7g) Tubes, Applicators and Cleansing Wipes.
NDC 68032-128-20.

River’s Edge Lidocaine HCI 3% - Hydrocortisone Acetate 2.5% Gel contains
20 Single-Use 1/4 oz. (7g) Tubes, Applicators and Cleansing Wipes.
NDC 68032-193-20.


KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 15º-30º C (59º-86º F). Protect from freezing.


PACKAGING:

The packaging below represents the current label being used.

Rx Only NDC 68032-124-20
Lidocaine HC 3% Hydrocortisone Acetate 0.5% Cream
CONTENTS:
20 Single-Use 1/4 oz. (7 g) Tubes, Applicators and Cleansing Wipes.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DIRECTIONS FOR RECTAL ADMINISTRATION:
1. Remove cleansing wipe from box, tear open the package, gently clean the affected area and discard cleansing wipe.
Note: The cleansing wipe does not contain any active ingredients.
2. Remove one child resistant tube and one applicator from package.
3. Remove child resistant cap from tube and attach applicator to the tube. Do not over tighten.
4. Prior to insertion, gently squeeze the tube until a small amount of cream comes out of the applicator openings.
This will lubricate the applicator tip.
5. Gently insert the applicator tip into the anal area. Continue squeezing the body of the tube as you move it around the areas
of discomfort, and lastly, around and in the anal opening (if directed by physician).
6. Do not completely insert the tube into the anus or insert deep into the rectum.
7. Discard empty tube and applicator.

WARNING: Product, used applicators and cleansing wipes could harm
small children if chewed or swallowed.

DESCRIPTION: Each River's Edge Lidocaine HCI 3% - Hydrocortisone Acetate 0.5%
7g tube contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 5 mg.
Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol,
Methylparaben, Mineral Oil, Polysorbate 60, Propylene Glycol, Propylparaben,
Purified Water (Aqua), Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol.

ADDITIONAL PRODUCT INFORMATION ENCLOSED.

CAUTION: For external use only. Not for ophthalmic
use. If irritation or sensitivity occurs or infection
appears, discontinue use and consult your physician.

DOSAGE AND ADMINISTRATION: Use twice daily
or as directed by a physician.

KEEP OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 15º - 30º C
(59º - 86º F). Protect from freezing.

Lidocaine HCI 3% Hydrocortisone Acetate 0.5% Cream Packaging1

Rx Only NDC 68032-128-20
Lidocaine HCI 3% Hydrocortisone Acetate 1% Cream
Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation
KIT CONTENTS:
20 Single-Use Units, Each Containing 1/4 oz. (7 g) Tube and Applicator.
Kit Also Contains 20 Cleansing Wipes.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

PATIENT DIRECTIONS FOR RECTAL ADMINISTRATION
1. Remove cleansing wipe from box, tear open, apply to affected area and discard.
2. Remove tube and single-use applicator from blister pack.
3. Remove cap from tube and attach applicator to the tube. Do not over tighten.
4. Squeeze the tube to fill the applicator until a small amount of cream shows and lubricate the end of the tip with cream.
5. Gently insert applicator tip with attached tube into anal area. Continue squeezing the body of the tube as it is moved around
the areas of discomfort and, if needed, around and in the anal opening (if directed by physician).
6. Do not completely insert the applicator and tube into the anus or insert deep into the rectum.
7. Discard empty tube and applicator.

WARNING: Product, used applicators and cleansing wipes could harm small children if chewed or swallowed. Individual tubes are NOT child resistant.
Keep the product inside the child resistant blister until ready to use.

DESCRIPTION: Each River's Edge Single-Use Tube contains Lidocaine HCI
USP 3% w/w and, Hydrocortisone Acetate USP 1% w/w in an acidic vehicle.
Inactive ingredients also include: Aluminum Sulfate, Calcium Acetate, Carbomer,
Cetyl Alcohol, Citric Acid , Glycerin, Glyceryl Monooleate, Methylparaben, Mineral
Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate,
Sodium Hydroxide, Sorbitan Monostearate, Stearic Acid, Stearyl Alcohol, Urea.

ADDITIONAL PRODUCT INFORMATION ENCLOSED.

CAUTION: For external use only. Not for ophthalmic use. If irritation
or sensitivity occurs or infection appears, discontinue use and consult
your physician.

DOSAGE AND ADMINISTRATION: Use twice daily or as directed by
a physician.

KEEP OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 15º - 30º C (59º - 86º F).
Protect from freezing.

Lidocaine HCI 3% Hydrocortisone Acetate 1% Cream Packaging1




LIDOCAINE HCI HYDROCORTISONE ACETATE CREAM 
lidocaine hci 3% hydrocortisone acetate 0.5% cream   cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-124
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE30 mg  in 7 g
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE5 mg  in 7 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-124-207 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other12/10/2006

LIDOCAINE HCI HYDROCORTISONE ACETATE CREAM 
lidocaine hci 3% hydrocortisone acetate1% cream   cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-128
Route of AdministrationRECTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE30 mg  in 7 g
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE10 mg  in 7 g
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-128-207 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved other12/10/2006

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 11/2009River's Edge Pharmaceuticals, LLC