SIGNATURE CARE HEMORRHOIDAL- mineral oil, petrolatum, and phenylephrine hci ointment 
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 Ointment 1 oz (with applicator) 78982 ZDP

Active ingredients                                               Purpose

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

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

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

Uses

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

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

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

Other information

Inactive ingredients

.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified 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 China

78982.1

SIGNATURE CARE HEMORRHOIDAL 
mineral oil, petrolatum, and phenylephrine hci ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-789
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL140 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
THYME OIL (UNII: 2UK410MY6B)  
ALCOHOL (UNII: 3K9958V90M)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-789-141 in 1 CARTON01/21/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/20/2016
Labeler - Better Living Brands, LLC (009137209)

Revised: 12/2022
Document Id: effad365-d76f-71af-e053-2995a90aa020
Set id: 3c8b43f3-6e1e-499e-ba71-ffdf836f6743
Version: 6
Effective Time: 20221216
 
Better Living Brands, LLC