SIGNATURE CARE HEMORRHOIDAL- glycerin, phenylephrine hci, pramoxine hci, and white petrolatum cream

Signature Care Hemorrhoidal by

Drug Labeling and Warnings

Signature Care Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by Better Living Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Glycerin 14.4%....................................................Skin Protectant

Phenylephrine HCI 0.25%...................................Vasoconstrictor

Pramoxine HCI 1%..............................................Local anesthetic

White petrolatum 15%.........................................Skin Protectant

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• difficulty in urination due to enlargement of the prostate gland
• diabetes

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

WHEN USING

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

Stop use and ask a doctor if

• condition worsens or does not improve within 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 increase

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

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 a soft cloth before applying cream
• when first opening the tube, puncture foil seal with top end of top
• apply externally or in the lower portion of the anal canal only
• apply 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 cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus
• thoroughly cleanse dispensing cap after each use and replace cover
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT

Inactive ingredients

aloe vera leaf, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate hydrate, stearic acid, tocopheryl acetate

DOSAGE & ADMINISTRATION

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Made in korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE HEMORRHOIDAL 
glycerin, phenylephrine hci, pramoxine hci, and white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-788
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	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
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-788-24	1 in 1 CARTON	12/01/2017
1		57 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	01/20/2016

Labeler - Better Living Brands, LLC (009137209)