Label: DR. BUTLER HEMORRHOID TREATMENT- phenylephrine hydrochloride 0.25%, witch hazel 50% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 70942-811-03 - Packager: Beyond Health P.A.
- 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 December 7, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.
Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, presently taking a prescription for high blood pressure or depression.
Stop use and ask a doctor if bleeding occurs, the condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, needed for longer than 1 week.
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Adults: when practical, cleanse the affected area by patting or blotting with Doctor Butler's Soothing Organic Wipes. Spray the rectal area until thoroughly moist. Wipe off excess with a 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.
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. BUTLER HEMORRHOID TREATMENT
phenylephrine hydrochloride 0.25%, witch hazel 50% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70942-811 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 Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) METHYLPARABEN (UNII: A2I8C7HI9T) ALCOHOL (UNII: 3K9958V90M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SULISOBENZONE (UNII: 1W6L629B4K) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) SODIUM CITRATE (UNII: 1Q73Q2JULR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70942-811-03 85 g in 1 CAN; Type 0: Not a Combination Product 12/07/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 12/07/2020 Labeler - Beyond Health P.A. (026781064) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs 116817470 manufacture(70942-811)
