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Signature Care Hemorrhoidal by Better Living Brands, LLC

Dosage form: ointment
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 1g, MINERAL OIL 140mg in 1g, PETROLATUM 749mg in 1g
Labeler: Better Living Brands, LLC
NDC Code: 21130-789

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.

Active ingredients                                               Purpose

Mineral oil 14%..............................................Protectant

Petrolatum 74.9%..........................................Protectant

Phenylephrine HCI 0.25%..........................Vasconstrictor

Uses

  • 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 bowel movements less painful

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

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

Ask a doctor of 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.

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into rectum causes additional pain

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 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 ointment.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement  
  • interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

Other information

  • store at 20-25°C (68-77°F)
  • Lot No. & Exp. Date: see box or see crimp of tube

Inactive ingredients

ethanol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax

Distributed by:

Better Living Brands LLC

P.O. Box 99

Pleasanton, CA 94566-0009

1-888-723-3929

www.betterlivingbrandsLLC.com

Made in Korea

SIGNATURE CARE HEMORRHOIDAL 
mineral oil, petrolatum, and phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-789
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE2.5 mg  in 1 g
MINERAL OIL (MINERAL OIL) MINERAL OIL140 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM749 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
LANOLIN 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
STEARYL ALCOHOL 
THYME OIL 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
WHITE WAX 
Packaging
#Item CodePackage Description
1NDC:21130-789-141 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/20/2016
Labeler - Better Living Brands, LLC (009137209)

Revised: 01/2016
 
Better Living Brands, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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