DR BUTLERS ADVANCED HEMORRHOID RELIEF- lidocaine hcl 5%, phenylephrine hcl 0.25%, witch hazel 50% spray

Dr Butlers Advanced Hemorrhoid Relief by

Drug Labeling and Warnings

Dr Butlers Advanced Hemorrhoid Relief by is a Otc medication manufactured, distributed, or labeled by Beyond Health. PA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine HCl 5%

Phenylephrine HCl 0.25%

Witch Hazel 50%

Purpose

External Analgesic

Vasoconstrictor

Astrigent

Uses

• temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders
• for the temporary relief of pain, soreness or burning
• temporarily reduces the swelling associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue

Warnings

For external use only.

Flammable

Do not use whie smoking or near heat or flame.

Do not use

in large quantities, particularly over raw surfaces or blistered areas. Do not exceed recommended dosage unless directed by a doctor.

When using this product

• keep out of eyes. Rinse eyes with water to remove
• do not put this product in the rectum by using fingers or any mechanical device or applicator

Ask a doctor or pharmacist before use if you have

• heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland
• are presently taking a prescription drug for high blood pressure or depression

Stop use and ask a doctor if

• condition worsens or does not improve within seven (7) 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 icrease

If pregnant or breastfeeding

ask a health professioal before use.

Keep out of reach of children.

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

Directions

• adults, when practical, cleanse the affected area by pattig or blotting with an appropriate cleansing pad
• gently dry by patting or blotting with toie tissue or soft cloth before application of this product
• shake well before using
• hold 3 to 6" away from rectal area, spray to moisten and then wipe off excess, if desired
• apply externally to the affected area up to 4 times daily
• chidren under 12 years of age, consult a doctor

Other Information

• store at 15º-30ºC (59º-86ºF)
• contents under pressure. Do not puncture or incinerate

Inactive ingredients

aesculus hippocastanum (horse chestnut) extract

alcohol

aloe barbadensis leaf extract

benzophenone-4

benzyl alcohol

calendula officinalis flower extract

carya ovata bark extract

centella asiatica extract

chamomilla recutita (matricaria) flower extract

curcuma longa (tumeric) root extract

disodium EDTA

epilobium angustifolium extract

ethylhexylglycerin

eucalyptus globulus leaf oil

glycerin

hammamelis virginiana (witch hazel) leaf extract

helichrysum italicum extract

hydroxyethylcellulose

lavandula angustifolia (lavender) flower extract

lysine HCl

melaluca alternifolia (tea tree) leaf extract

mentha piperita (peppermint) oil

olea europaea (olive) leaf extract

panax ginsing root extract

polysorbate 40

propylene glycol

rosmarinus officinalis (rosemary) leaf extract

sodium citrate

sodium hyaluronate

tocopherol

tocopherol acetate

water

5oz / 142g can

INGREDIENTS AND APPEARANCE

DR BUTLERS ADVANCED HEMORRHOID RELIEF 
lidocaine hcl 5%, phenylephrine hcl 0.25%, witch hazel 50% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70942-127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	50 g  in 100 g
LIDOCAINE HCL (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)
OLEA EUROPAEA (OLIVE) LEAF (UNII: MJ95C3OH47)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ROSEMARY (UNII: IJ67X351P9)
CHAMOMILE (UNII: FGL3685T2X)
EUCALYPTUS OIL (UNII: 2R04ONI662)
POLYSORBATE 40 (UNII: STI11B5A2X)
TOCOPHEROL (UNII: R0ZB2556P8)
CARYA OVATA BARK (UNII: X765CF609L)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
ALCOHOL (UNII: 3K9958V90M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TURMERIC (UNII: 856YO1Z64F)
LYSINE HCL (UNII: JNJ23Q2COM)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZOPHENONE-4 (UNII: 1W6L629B4K)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
PEPPERMINT OIL (UNII: AV092KU4JH)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)
LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER (UNII: 19AH1RAF4M)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70942-127-05	142 g in 1 CAN; Type 0: Not a Combination Product	07/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	07/22/2024

Labeler - Beyond Health. PA (026781064)