HEMORRHOIDAL ANESTHETIC- glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream 
Purity Products

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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Hemorrhoidal Cream
Anesthetic

Drug Facts

Active IngredientsPurposes
Glycerin 14.4%Protectant
Phenylephrine HCl 0.25%Vasoconstrictor
Pramoxine HCl 1%Local Anesthetic
White petrolatum 15%Protectant

Uses

Warnings

For external use only

Ask a doctor before use if you have

  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty urinating due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are 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 into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • Bleeding occurs the condition worsens or does not improve within 7 days
  • An allergic reaction develops
  • The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

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 Ingredient

Aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, cetyl alcohol, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, sodium carboxymethyl cellulose, steareth-2, steareth-20, stearyl alcohol, vitamin E acetate, xanthan gum

Questions or comments?

To Reorder Call: 1-800-281-7781, Customer Care: 1-888-769-7873 or www.purityproducts.com

PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton

NET WT.
0.9 OZ (25.5 G)

Save
Uranus

RAPID
SOOTHING

Relief & Comfort

MAXIMUM STRENGTH FOR PAINFUL
BURNING, ITCHING, & DISCOMFORT.

PRINCIPAL DISPLAY PANEL - 25.5 G Tube Carton
HEMORRHOIDAL  ANESTHETIC
glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, and petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71003-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
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
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM150 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-23 (UNII: N72LMW566G)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PANTHENOL (UNII: WV9CM0O67Z)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-20 (UNII: L0Q8IK9E08)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71003-001-011 in 1 CARTON10/20/2016
125 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34610/20/2016
Labeler - Purity Products (807859509)
Establishment
NameAddressID/FEIBusiness Operations
Natureplex062808196MANUFACTURE(71003-001)

Revised: 10/2016
Document Id: ec8baea0-4012-4619-bb68-91cc10cd2fda
Set id: fe25bc32-e37a-45ab-887c-f0332b6cf990
Version: 1
Effective Time: 20161025
 
Purity Products