TREATONIC HEMORRHOID TREATMENT- 5% lidocaine cream

Treatonic hemorrhoid treatment by

Drug Labeling and Warnings

Treatonic hemorrhoid treatment by is a Otc medication manufactured, distributed, or labeled by 100 KARMA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

• Lidocaine 5%
• Phenylephrine HCI 0.25%

PURPOSE

• Topical anesthetic
• Vasoconstrictor

DOSAGE & ADMINISTRATION

• For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.
• For the temporary reliefofpain, burning and soreness.
• Temporarily shrinks hemorrhoidal tissue.
• Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.

WARNINGS

For external and / or intrarectal use only.

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

• Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
• Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain.
• Consult a doctor promptly.

• lf the condition worsens or does not improve within 7 days, consult a doctor.
• Do not exceed the recommended daily dosage unless directed by a doctor.
• In case of bleeding, consult a doctor promptly.
• Certain persons can develop allergic reactions to ingredients in this product.
• If the symptombeing treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Keep out of reach of children, if swallowed, get medical help or contact poison control center right away.

INDICATIONS & USAGE

• Adults: 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 of this product. Children under 12 years of age: consult a doctor.
• For External use: Apply externally to the affected area up to 4 times daily.
• For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.

OTHER SAFETY INFORMATION

• Keep away from direct sunlight or heat.
• Store at room temperature 15°-30°C(59°-86°F).
• This package is child-resistant. Keep out of reach of children.
• In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

INACTIVE INGREDIENT

Water, Ethylhexyl Palmitate, Zinc Oxide, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Gentiana Scabra Root Extract, Centella Asiatica Extract, Menthol, PEG-100 Stearate, Carbomer, Allantoin, Salvia Miltiorrhiza Root Extract, Angelica Polymorpha Sinensis Root Extract, Eugenia Caryophyllus (Clove) Bud Extract, Glycyrrhiza Uralensis (Licorice) Root
Extract, Dendrobium Officinale Stem Extract, Stephania Tetrandra Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Taxus Cuspidata Leaf Extract, Smilax Glabra Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Potassium Alum, Caprylhydroxamic Acid, Phenoxyethanol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TREATONIC HEMORRHOID TREATMENT 
5% lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85569-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2.5 g  in 50 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.125 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
CLOVE (UNII: K48IKT5321)
SMILAX GLABRA WHOLE (UNII: H51N91QNEB)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEPHANIA TETRANDRA ROOT (UNII: 48PS81XHK0)
MENTHOL (UNII: L7T10EIP3A)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
POTASSIUM ALUM (UNII: 1L24V9R23S)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CARBOMER (UNII: 0A5MM307FC)
SALVIA MILTIORRHIZA ROOT (UNII: 1693AM5SBN)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALLANTOIN (UNII: 344S277G0Z)
GENTIANA SCABRA ROOT (UNII: GXZ33VNT92)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
WATER (UNII: 059QF0KO0R)
DENDROBIUM OFFICINALE STEM (UNII: VT53B5BP4G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TAXUS CUSPIDATA LEAF (UNII: 8M03K6M7S8)
ZINC OXIDE (UNII: SOI2LOH54Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85569-008-01	50 g in 1 CARTON; Type 0: Not a Combination Product	10/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/31/2025

Labeler - 100 KARMA INC (120186232)

Registrant - 100 KARMA INC (120186232)