Label: REVIVOL HEMORRHOID AND FISSURE- glycerin 14.4%, lidocaine 5%, petrolatum 15%, phenylephrine hcl 0.25% cream
- NDC Code(s): 72839-295-01
- Packager: Derma Care Research Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 24, 2023
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- ACTIVE INGREDIENT
- PURPOSE
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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.
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WARNINGS
For external and/or intrarectal use.
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 do not exceed recommended dosage unless directed by a doctor.
Stop use and ask a doctor if condition worsens or does not improve within seven (7) days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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. Apply externally 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.
For intrarectal use: attach applicator to tube. Lubricate well, then gently insert applicator into the rectum. Thoroughly cleanse applicator after use with mild soap and warm water and rinse thoroughly.
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INACTIVE INGREDIENT
Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, BHA, calendula officinalis extract, cellulose gum, centella asiatica extract, 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
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INGREDIENTS AND APPEARANCE
REVIVOL HEMORRHOID AND FISSURE
glycerin 14.4%, lidocaine 5%, petrolatum 15%, phenylephrine hcl 0.25% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72839-295 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 CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) HORSE CHESTNUT (UNII: 3C18L6RJAZ) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) MINERAL OIL (UNII: T5L8T28FGP) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) CETYL ALCOHOL (UNII: 936JST6JCN) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) PANTHENOL (UNII: WV9CM0O67Z) 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) 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:72839-295-01 1 in 1 CARTON 05/12/2023 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 final M015 05/12/2023 Labeler - Derma Care Research Labs, LLC (116817470) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(72839-295)