DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (0.25 g) Lidocaine (5 g) Hamamelis Virginiana (witch Hazel) Leaf Water (42.5 g)

Inactive Ingredients

Water Alcohol Ethylhexylglycerin Benzophenone-4 .alpha.-tocopherol Acetate Propylene Glycol Polysorbate 20 Aloe Barbadensis Leaf Edetate Disodium Anhydrous Citric Acid Phenoxyethanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-04

Medication Information

Indications and Usage

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

Dosage and Administration

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.

Description

Witch Hazel Distillate 42.50% Lidocaine HCl 5.00% Penylephrine HCI 0.25%

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50568-5

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.

Section 51727-6

Alcohol

Aloe Barbadensis Leaf

Benzophenone-4

Disodium EDTA

Tocopheryl Acetate

Ethylhexylglycrin

Phenoxyethanol

Polysorbate-20

Propylene Glycol

Sodium Citrate

Water

Section 51945-4

Section 53413-1

Question? 1-855-myderm1

Section 53414-9

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

Section 55105-1

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

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

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

Section 55106-9

Witch Hazel Distillate 42.50%

Lidocaine HCl 5.00%

Penylephrine HCI 0.25%

Warning

For external use only

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)

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.

Section 51727-6 (51727-6)

Alcohol

Aloe Barbadensis Leaf

Benzophenone-4

Disodium EDTA

Tocopheryl Acetate

Ethylhexylglycrin

Phenoxyethanol

Polysorbate-20

Propylene Glycol

Sodium Citrate

Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question? 1-855-myderm1

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

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

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

Section 55106-9 (55106-9)

Witch Hazel Distillate 42.50%

Lidocaine HCl 5.00%

Penylephrine HCI 0.25%

Warning

For external use only

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZOPHENONE-4", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE BARBADENSIS LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER", "unii": "8FP93ED6H2", "classCode": "ACTIB", "strengthNumerator": "42.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Temporary shrinks hemorrhoidal tissue •Temporarily reduces swelling associated with irritated anorectal areas.", "34068-7": "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.", "50565-1": "Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately", "50566-9": "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", "50567-7": "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", "50568-5": "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.", "51727-6": "Alcohol Aloe Barbadensis Leaf Benzophenone-4 Disodium EDTA Tocopheryl Acetate Ethylhexylglycrin Phenoxyethanol Polysorbate-20 Propylene Glycol Sodium Citrate Water", "53413-1": "Question? 1-855-myderm1", "53414-9": "If pregnant or breast-feeding , ask a health professional before use", "55105-1": "Witch Hazel Distillate .......................Anesthetic Lidocaine HCl 5.00% .......................Anesthetic Penylephrine HCI 0.25% .................Vasoconstrictor", "55106-9": "Witch Hazel Distillate 42.50% Lidocaine HCl 5.00% Penylephrine HCI 0.25%", "Warning": "For external use only"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information