SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR)- phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, 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 2 oz. ZDP 78981

Active ingredients Purpose

Glycerin 14.4%............................................................Skin protectant

Phenylephrine HCl 0.25%...........................................Vasconstrictor

Pramoxine HCl 1%......................................................Local anesthetic

White petrolatum 15%.................................................Skin protectant

Uses

Warnings

For external and/or intrarectal use only

Ask a doctor before use if you have

When using this product

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 Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

.alpha.-tocopherol acetate, aloe vera leaf, anhydrous lanolin, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, glycryl monostearate, isopropyl myristate, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, steareth-20, stearic acid, trisodium citrate dihydrate

Distributed by:

Better Living Brands LLC

Made in China

78981.1

SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR) 
phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-981
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STEARETH-20 (UNII: L0Q8IK9E08)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LANOLIN (UNII: 7EV65EAW6H)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-981-021 in 1 CARTON01/04/2021
157 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/04/2021
Labeler - BETTER LIVING BRANDS, LLC (009137209)
Registrant - United Exchange Corp. (840130579)

Revised: 1/2021
Document Id: b818fe52-e46a-0291-e053-2a95a90ad31b
Set id: b026a386-5e38-52ed-e053-2a95a90a6b0e
Version: 2
Effective Time: 20210104
 
BETTER LIVING BRANDS, LLC