DOCTOR BUTLER HEMORRHOID AND FISSURE ADVANCED FORMULA- glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment 
Beyond Health, PA

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.

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Doctor Butler Advanced Formula

Glycerin 37.5%, Lanolin 12.5%, Lidocaine 4%, Zinc Oxide 5%

Anorectal (Hemorrhoidal)

Uses

Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

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.

If pregnant or breastfeeding, ask a health care professional before use.

Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Carton

DOCTOR BUTLER HEMORRHOID AND FISSURE  ADVANCED FORMULA
glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-517
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN37.5 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN12.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70942-517-011 in 1 CARTON09/20/2021
142.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34609/20/2021
Labeler - Beyond Health, PA (026781064)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derrma Care Research Labs116817470manufacture(70942-517)

Revised: 1/2023
Document Id: f1db01ad-6aab-798f-e053-2a95a90ad648
Set id: d2a769e2-afd0-aed2-e053-2995a90ad429
Version: 2
Effective Time: 20230109
 
Beyond Health, PA