MYDERM MEDICAL NEW SOOTHING HEMORRHOIDAL- witch hazel penylephrine lidocaine spray

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients                                                            Purpose

Witch Hazel Extract 50.00%.....................................................Anesthetic
Lidocaine HCl 5.00%................................................................Anesthetic
Phenylephrine Hydrochloride 0.25%................................Vasoconstrictor

PURPOSE

Uses

Temporarily shrinks hemorrhoidal tissue. Temporarily reduces
swelling associated with irritation Helps protect irritated anorectal areas.

Directions 

Adults and children 2 years of age and older: Apply to
affected area not more than 3 to 4 times daily. Children under 2 years
of age: Consult physician.

Warnings For external use only.

When using this product avoid spraying in eyes. contents under
pressure. do not puncture or incinerate. do not store at temperature
above 120° F. do not exceed recommended daily dosage unless
directed by doctor. do not put this product into rectum by using fingers
or any mechanical device or applicator.

Ask a doctor or pharmacist before use ifyou have heart disease,
high blood pressure, thyroid disease, diabetes, difficulty in urination due
to enlargement of prostate gland. are presently taking a prescription
drug for high blood pressure or depression.

Stop use and ask doctor if condition worsens, or if symptoms persist
for more than 7 days, or clear up and reoccur again within a few days.
If pregnant or breastfeeding, ask a healthcare professional before use.

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center immediately.

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf,
Benzophenone-4, Disodium EDTA, Tocopheryl Acetate, Ethylhexylglycrin,
Phenoxyethanol, Polysorbate-20, Propylene Glycol,
Sodium Citrate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM MEDICAL NEW SOOTHING HEMORRHOIDAL 
witch hazel penylephrine lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ALOE (UNII: V5VD430YW9)
BENZOPHENONE-4 (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-287-05	127 g in 1 CAN; Type 0: Not a Combination Product	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	12/01/2025

Labeler - Inspec Solutions (081030372)

Registrant - Inspec Solutions (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(72667-287)