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

HEMORRHOID AND FISSURE  DR. BUTLER
lidocaine 4.00 phenylephrine hydrochloride 0.25 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	Lidocaine	4 g  in 100 g
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-010-01	1 in 1 CARTON	08/28/2007
1		28 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	08/28/2007	09/07/2019

Labeler - Beyond Health P.A. (026781064)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(70942-010) , label(70942-010)

Revised: 3/2018

Document Id: c58b06e0-c61c-4460-b7fc-496bf0d9e956

34390-5

Set id: 0e059e73-6a64-44b0-af56-6de72a2cd1f0

Version: 3

Effective Time: 20180305