DERMATOOL HEMORRHOIDAL- glycerin, lidocaine, petrolatum, phenylephrine hcl cream

Dermatool Hemorrhoidal by

Drug Labeling and Warnings

Dermatool Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Papalo Group LLC, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%

PURPOSE

Anorectal/Hemorrhoidal

INDICATIONS & USAGE

For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

WARNINGS

For external use only.

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland.

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

When using this product: avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if: rectal bleeding occurs, condition worsens or does not improve within seven (7) days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, symptoms clear up and return within a few days.

PREGNANCY OR BREAST FEEDING

Ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, seek medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hamamelis virginiana (witch hazel) leaf extract, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMATOOL HEMORRHOIDAL 
glycerin, lidocaine, petrolatum, phenylephrine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84728-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARETH-21 (UNII: 53J3F32P58)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84728-413-01	1 in 1 CARTON	05/10/2023
1		42.5 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 Drug	M015	05/10/2023

Labeler - Papalo Group LLC (119324672)

Registrant - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(84728-413)