Label: SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM- phenylephrine hydrochloride, pramoxine hydrochloride cream
- NDC Code(s): 83311-335-00
- Packager: SIMPLE PROMISE PTE LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 6, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
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Uses
• for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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Warnings
For external use only
Do not use
this product if you have
• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • unless directed by a doctor.
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.
• attach the applicator to the tube. Lubricate the applicator well, then gently insert the applicator into the rectum. FOR INTRARECTAL USE:
In case of bleeding, consult a doctor promptly.
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Directions
• : 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 cap • 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 Children under 12 years of age: ask a doctor. Adults
- Other information
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Inactive ingredients
Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Dimethicone, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Hamamelis Virginiana (Witch Hazel), Isopropyl Myristate, PEG-100 Stearate, Petrolatum, Polysorbate-20, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.
- Package Labeling: SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, 2oz/56.7g
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INGREDIENTS AND APPEARANCE
SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM
phenylephrine hydrochloride, pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83311-335 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 2.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61) SHEA BUTTER (UNII: K49155WL9Y) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) CUCUMBER (UNII: YY7C30VXJT) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL LAURATE (UNII: Y98611C087) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) PEG-100 STEARATE (UNII: YD01N1999R) PETROLATUM (UNII: 4T6H12BN9U) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83311-335-00 1 in 1 BOX 03/06/2023 1 56.7 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M015 03/06/2023 Labeler - SIMPLE PROMISE PTE LTD (659554958)
