REXALL MAXIMUM STRENGTH HEMORRHOIDAL- glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream 
Dolgencorp, Inc.

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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Rexall Maximum Strength Hemorrhoidal

Active ingredients  
Glycerin 14.4%
Petrolatum 15%
Phenylephrine Hydrochloride 0.25%
Pramoxine HCl 1%

Purpose

Protectant
Protectant
Vasoconstrictor
Local anesthetic

Uses

Warnings

For external use only.

Ask a doctor before use if you have

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

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 right away.

Directions

Other information

Inactive ingredients

aloe barbadensis leaf, cetearyl alcohol, cetyl alcohol, glycerol monostearate,  mineral oil, peg 40 castor oil, propylene glycol, purified water, 
stearyl alcohol, tocopheryl acetate (Vitamin E).

PRINCIPAL DISPLAY PANEL

REXALL MAXIMUM STRENGTH HEMORRHOIDAL

NET WT 1 OZ (28 g)

label of rexall

REXALL MAXIMUM STRENGTH HEMORRHOIDAL 
glycerin, petrolatum, phenylephrine hydrochloride and pramoxine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-406
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-406-0328 g in 1 TUBE; Type 0: Not a Combination Product06/29/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/29/2016
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-406)

Revised: 7/2016
Document Id: 36a96992-0a52-1323-e054-00144ff88e88
Set id: 68c364eb-ca88-4885-8d9e-6ec512266f0a
Version: 1
Effective Time: 20160701
 
Dolgencorp, Inc.