DR BUTLERS HEMORRHOID AND FISSURE PF- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment 
Beyond Health P.A.

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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Dr Butler Hemorrhoid & Fissure Ointment PF

Lidocaine 4%, Phenylephrine HCl 0.25%

Analgesic (pain relief), Vasoconstrictor

Temporarily shrinks hemorrhoidal tissue, for the temporary relief of pain, soreness, or burning, and helps relieve the local itching and discomfort associated with hemorrhoids.

For external use only including the skin of the anal canal.

When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only. Do not put this product into the rectum.

Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.

Stop use and ask a doctor if condition worsens or does not improve within seven 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.

If swallowed, seek medical help or contact a Poison Control Center right away.

Children under 12 years of age consult your pediatrician.

Adults: apply to affected area up to 3 times daily.

Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, octyldodecanol, olea europaea (olive) fruit oil, panax ginseng root extract, PEG-8 dimehticone, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, pyridoxine HCl, retinyl palmitate, silica, sodium hyaluronate, sodium propoxyhydroxypropyl thiosulfate silica, stearic acid, tocopheryl acetate, triethoxycaprylysilance, water, zea mays (corn) oil, zinc oxide

If pregnant or breast-feeding, ask a health care professional before use.

Carton

DR BUTLERS HEMORRHOID AND FISSURE PF 
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
ALOE (UNII: V5VD430YW9)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
TRICAPRYLIN (UNII: 6P92858988)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
HYDROCORTISONE (UNII: WI4X0X7BPJ)  
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
MINERAL OIL (UNII: T5L8T28FGP)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
CORN OIL (UNII: 8470G57WFM)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70942-357-011 in 1 CARTON02/20/2023
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/20/2023
Labeler - Beyond Health P.A. (026781064)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(70942-357)

Revised: 2/2023
Document Id: f526199e-5c9d-7a3c-e053-2a95a90aa98e
Set id: f526199e-5c9e-7a3c-e053-2a95a90aa98e
Version: 1
Effective Time: 20230220
 
Beyond Health P.A.