HEMORRHOID AND FISSURE DR. BUTLER- 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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Analgesic (pain relief), Vasoconstrictor

Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

For external and/or intrarectal use only.

When using this product do not exceed recommended daily dosage unless directed by a doctor.

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. 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. Introduction of applicator into the rectum causes additional pain.

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

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.

Cartonimage descriptionimage description

HEMORRHOID AND FISSURE  DR. BUTLER
lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-023
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)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
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)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
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:70942-023-011 in 1 CARTON08/28/2007
128 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70942-023-111 in 1 CARTON08/27/2019
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34608/28/2007
Labeler - Beyond Health P.A. (026781064)
Registrant - Derma Care Research Labs (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(70942-023)

Revised: 7/2020
Document Id: aaa3f1c1-c2f7-578f-e053-2a95a90a2860
Set id: 828039c3-af65-de83-e053-2991aa0a2a93
Version: 3
Effective Time: 20200717
 
Beyond Health P.A.