Label: DOCTOR BUTLER HEMORRHOID AND FISSURE ADVANCED FORMULA- glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment
- NDC Code(s): 70942-517-01
- Packager: Beyond Health, PA
- 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 January 9, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
WARNINGS
For external and/or intrarectal use only.
When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor. Certain persons can develop allergic reactions to ingredients in this product. If the symptom 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 before use if you have allergies to any of the components of this product.
Stop use and ask a doctor if condition worsens or does not improve within seven days or bleeding occurs.
- PREGNANCY
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- Children under 12 years of age consult your pediatrician.
- Adults: Apply to the affected area up to 3 times daily.
- Clean affected area with mild soap and warm water, rinse thoroughly, and gently dry (patting or blotting) with tissue or soft cloth before use.
- The ointment can be applied using a gloved finger or finger cot.
- To use finger cots: roll one finger cot over finger. Gently squeeze ointment onto finger cot. Smooth a layer of the ointment over affected area or into anus.
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INACTIVE INGREDIENT
Aesculus Hippocastanum (Horse Chestnut) Extract
Algae Extract
Argania Spinosa Kernel Oil
Benzyl Alcohol
Calendula Officinalis Flower Extract
Camellia Sinensis Leaf Extract
Cananga Odorata Flower Oil
Canola Oil
Caprylhydroxamic Acid
Caprylic/Capric Triglyceride
Centella Asiatica Extract
Chamomilla Recutita (Matricaria) Flower Extract
Cocos Nucifera (Coconut) Oil
Curcuma Longa (Turmeric) Root Extract
Euphorbia Cerifera (Candelilla) Wax
Glyceryl Caprylate
Helianthus Annuus (Sunflower) Seed Oil
Helianthus Annuus (Sunflower) Seed Wax
Hydrocortisone
Lavandula Angustifolia (Lavender) Oil
Linum Usitatissimum (Linseed) Seed Oil
Lysine HCl
Macadamia Ternifolia Seed Oil
Olea Europaea (Olive) Fruit Oil
Panax Ginseng Root Extract
Persea Gratissima (Avocado) Oil
Pogostemon Cablin Oil
Polyhydroxystearic Acid
Punica Granatum Fruit Extract
Ricinus Communis (Castor) Seed Oil
Rosa Canina Seed Oil
Sodium Hyaluronate
Tocopheryl Acetate
Triethoxycaprylylsilane
Viburnum Opulus Bark Extract
Water
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DOCTOR BUTLER HEMORRHOID AND FISSURE ADVANCED FORMULA
glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70942-517 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 37.5 g in 100 g LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 g LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN 12.5 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) VIBURNUM OPULUS WHOLE (UNII: DIO510WJ04) WATER (UNII: 059QF0KO0R) ASIAN GINSENG (UNII: CUQ3A77YXI) AVOCADO OIL (UNII: 6VNO72PFC1) POMEGRANATE (UNII: 56687D1Z4D) CANDELILLA WAX (UNII: WL0328HX19) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) HYDROCORTISONE (UNII: WI4X0X7BPJ) CASTOR OIL (UNII: D5340Y2I9G) ROSA CANINA SEED OIL (UNII: MHT97MG5P8) MACADAMIA OIL (UNII: 515610SU8C) OLIVE OIL (UNII: 6UYK2W1W1E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) SUNFLOWER OIL (UNII: 3W1JG795YI) LAVENDER OIL (UNII: ZBP1YXW0H8) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) LINSEED OIL (UNII: 84XB4DV00W) COCONUT OIL (UNII: Q9L0O73W7L) CHAMOMILE (UNII: FGL3685T2X) CANOLA OIL (UNII: 331KBJ17RK) CANANGA OIL (UNII: 8YOY78GNNX) HORSE CHESTNUT (UNII: 3C18L6RJAZ) TURMERIC (UNII: 856YO1Z64F) ARGAN OIL (UNII: 4V59G5UW9X) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) BENZYL ALCOHOL (UNII: LKG8494WBH) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70942-517-01 1 in 1 CARTON 09/20/2021 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 part346 09/20/2021 Labeler - Beyond Health, PA (026781064) Registrant - Derma Care Research Labs (116817470) Establishment Name Address ID/FEI Business Operations Derrma Care Research Labs 116817470 manufacture(70942-517)
