Label: REXALL MAXIMUM STRENGTH HEMORRHOIDAL- glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream
- 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.
Updated July 1, 2016
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
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
- do not put this product into rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- bleeding occurs
- condition gets worse or does not improve within 7 days
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
- Adults: when practical, cleanse and gently dry the affected area by patting or blotting with an appropriate cleansing tissue or soft cloth before applying.
- when first opening the tube, puncture foil seal with top end of cap.
- 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
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
REXALL MAXIMUM STRENGTH HEMORRHOIDAL
glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-406 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 14.4 g in 100 g PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 15 g in 100 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 0.25 g in 100 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-406-03 28 g in 1 TUBE; Type 0: Not a Combination Product 06/29/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 06/29/2016 Labeler - Dolgencorp, Inc. (068331990) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(55910-406)