HEMORRHOIDAL ANESTHETIC- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream

Hemorrhoidal by

Drug Labeling and Warnings

Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Purity Products, Natureplex. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purposes
Glycerin 14.4%	Protectant
Phenylephrine HCl 0.25%	Vasoconstrictor
Pramoxine HCl 1%	Local Anesthetic
White petrolatum 15%	Protectant

Uses

• For temporary relief of pain, soreness and burning
• Helps relieve the local itching and discomfort associated with hemorrhoids
• Temporarily shrinks hemorrhoidal tissue and relieves burning
• Temporarily provides a coating for relief of anorectal discomforts
• Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

For external use only

Ask a doctor before use if you have

• Heart disease
• High blood pressure
• Thyroid disease
• Diabetes
• Difficulty urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking a prescription drug for high blood pressure or depression

When using this product

• Do not exceed the recommended daily dosage unless directed by a doctor
• Do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

• Bleeding occurs the condition worsens or does not improve within 7 days
• An allergic reaction develops
• The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding, ask a health professional 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 patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying the cream
• When first opening the tube, remove the foil seal
• Apply externally or in the lower portion of the anal canal only
• Apply externally to the affected area up to 4 times daily, especially at night, in the morning, or after each bowel movement
• For application in the lower anal canal; remove the cover from the dispensing cap. Attach the dispensing cap to the tube. Lubricate the dispensing cap well, then gently insert the dispensing cap partway into the anus.
• Thoroughly cleanse the dispensing cap after each use, and replace the cover
• Children under 12 years: ask a doctor

Other Information

• Store at 15 to 30°C (59 to 86°F)

Inactive Ingredient

Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum

Questions or comments?

To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com

PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton

NET WT.
0.9 OZ (25.5 G)

Save
Uranus

RAPID
SOOTHING
Relief & Comfort

MAXIMUM STRENGTH FOR PAINFUL
BURNING, ITCHING, & DISCOMFORT.

INGREDIENTS AND APPEARANCE

HEMORRHOIDAL  ANESTHETIC
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71003-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LAURETH-23 (UNII: N72LMW566G)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYL GALLATE (UNII: 8D4SNN7V92)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71003-001-01	1 in 1 CARTON	10/20/2016
1		25 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	10/20/2016

Labeler - Purity Products (807859509)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex		062808196	MANUFACTURE(71003-001)