MYDERM- penylephrine hci, witch hazel, lidocaine hcl, spray

MyDerm by

Drug Labeling and Warnings

MyDerm by is a Otc medication manufactured, distributed, or labeled by Inspec Solution LLC., Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingerdients

Witch Hazel Distillate 42.50%

Lidocaine HCl 5.00%

Penylephrine HCI 0.25%

Purpose

Witch Hazel Distillate .......................Anesthetic

Lidocaine HCl 5.00% .......................Anesthetic

Penylephrine HCI 0.25% .................Vasoconstrictor

Uses

Uses: Temporary shrinks hemorrhoidal tissue Temporarily reduces swelling associated with irritated anorectal areas.

Warning

For external use only

When using this product

When using this product avoid spraying in eye content 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

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

Stop use and ask doctor

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 breast-feeding

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Directions For adults and children 12 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.

Question?

Question? 1-855-myderm1

Inactive Ingredient

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 
penylephrine hci, witch hazel, lidocaine hcl, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER (UNII: 8FP93ED6H2) (HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER - UNII:8FP93ED6H2)	HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER	42.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZOPHENONE-4 (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM HYDROGEN CITRATE (UNII: 6FO62KCQ7A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-081-01	127 g in 1 CAN; Type 0: Not a Combination Product	11/04/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	11/04/2024

Labeler - Inspec Solution LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(72667-081)