SIGNATURE CARE HEMORRHOIDAL- glycerin, phenylephrine hci, pramoxine hci, and white petrolatum cream 
Better Living Brands, LLC

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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Signature Care Hemorrhoidal Cream 2oz (78981, 2018)

Active ingredients Purpose

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

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

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

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

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

For external use only

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 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

  • 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

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 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

Other information

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

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

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Made in korea

78981

SIGNATURE CARE HEMORRHOIDAL 
glycerin, phenylephrine hci, pramoxine hci, and white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-788
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
.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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-788-241 in 1 CARTON12/01/2017
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/20/201612/16/2020
Labeler - Better Living Brands, LLC (009137209)

Revised: 12/2021
 
Better Living Brands, LLC