Frug Facts

Drug Labeling and Warnings

Drug Details [pdf]

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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Frug Facts

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HEMORRHOID AND FISSURE  DR. BUTLER
lidocaine 4.00 phenylephrine hydrochloride 0.25 ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70942-010
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: 70942-010-011 in 1 CARTON08/28/2007
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 finalpart34608/28/200709/07/2019
Labeler - Beyond Health P.A. (026781064)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(70942-010) , label(70942-010)

Revised: 3/2018
 

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