Label: LIDOCAINE HEMORRHOID- lidocaine hcl, phenylephrine hcl, witch hazel spray
- NDC Code(s): 0363-1657-03
- Packager: Walgreens Co
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 5, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INDICATIONS & USAGE
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WARNINGS
For external use only.
Flammable. Do not use while smoking or near heat or flame.
When using this product
- keep away from children
- avoid spraying in eyes
- contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
- certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
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 the prostate gland
- are presently taking a prescription drug for high blood pressure or depression
Stop use and ask a doctor if
- bleeding occurs
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- needed for longer than 1 week
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
- Adults: when practical, cleanse the affected are with an appropriate cleansing wipe.
- Spray rectal area until thoroughly moist. Wipe off excess with tissue.
- Gently dry by patting or blotting with a tissue or a soft cloth.
- Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
- Children under 12 years of age, consult a doctor.
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INACTIVE INGREDIENT
alcohol, aloe barbadensis leaf extract, anthemis nobilis flower extract, benzophenone-4, benzyl alcohol, centella asiatica extract,disodium EDTA, epilobium angustifolium extract, ethylhexylglycerin, glycerin, hydroxyethylcellulose, polysorbte 40, propylene glycol, sodium citrate, tocopherol, tocopheryl acetate, water.
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INGREDIENTS AND APPEARANCE
LIDOCAINE HEMORRHOID
lidocaine hcl, phenylephrine hcl, witch hazel sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1657 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 HYDROCHLORIDE 0.25 g in 100 g LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 5 g in 100 g Inactive Ingredients Ingredient Name Strength CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) POLYSORBATE 40 (UNII: STI11B5A2X) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) SULISOBENZONE (UNII: 1W6L629B4K) BENZYL ALCOHOL (UNII: LKG8494WBH) ALCOHOL (UNII: 3K9958V90M) EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TOCOPHEROL (UNII: R0ZB2556P8) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1657-03 85 g in 1 CAN; Type 0: Not a Combination Product 02/05/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 02/05/2024 Labeler - Walgreens Co (008965063) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(0363-1657)