Label: SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR)- phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum cream
- NDC Code(s): 21130-981-02
- Packager: BETTER LIVING BRANDS, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 4, 2021
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ACTIVE INGREDIENT
Active ingredients Purpose
Glycerin 14.4%............................................................Skin protectant
Phenylephrine HCl 0.25%...........................................Vasconstrictor
Pramoxine HCl 1%......................................................Local anesthetic
White petrolatum 15%.................................................Skin protectant
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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 make bowel movements less painful
- WARNINGS
- ASK DOCTOR
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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, peel back foil seal
- apply externally or in the lower portion of the anal canal only
- apply externally 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
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INACTIVE INGREDIENT
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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIGNATURE CARE HEMORRHOIDAL CREAM (WITH APPLICATOR)
phenylephrine hydrochloride, pramoxine hydrochloride, glycerin, petrolatum creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-981 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 144 mg in 1 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 150 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:21130-981-02 1 in 1 CARTON 01/04/2021 1 57 g in 1 TUBE, WITH APPLICATOR; 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 01/04/2021 Labeler - BETTER LIVING BRANDS, LLC (009137209) Registrant - United Exchange Corp. (840130579)