CVS HEALTH  HEMORRHOIDAL CREAM- glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream 
FRONT PHARMACEUTICAL PLC

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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CVS Health Hemorrhoidal Cream, 28g

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Purpose

Glycerin 14.4% ...........................Protectant

Phenylephrine HCl 0.25% .............Vasoconstrictor

Pramoxine HCl 1%........................Local anesthetic

White petrolatum 15%..................Protectant

Uses  •for temporary relief of pain, soreness and burning •helps relieve

the local itching and discomfort associated ith hemorrhoids

•temporarily provides a coating for f of anorectal discomforts

•temporarily protects the inflamed irritated anorectal surface to help make

bowel movements less painful  •temporarily shrinks hemorrhoidal tissue

Warnings

For external use only.

When using this product •do not put this product into the rectum by

using fingers or any mechanical device or applicator •do not exceed

recommended daily dosage unless directed by a doctor

Ask a doctor before use ifyou have

•heart disease •high blood pressure •thyroid disease •diabetes

•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 depsression

Stop use and ask a doctor if

•bleeding occurs •condition worsens or does not improve within 7 days

•if the symptoms being treated do not subside or if redness, irritation,

swelling, pain or other symptoms develop or increase. Some people can

develop allergic reactions to ingredients in this product.

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 Adults:

•when practical, cleanse the affected area with mild soap and water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

•apply externally to the affected area up to 4 times daily, especially at night or in the

morning or after each bowel movement.

Children under 12 years of age: consult a doctor.

Other information store at room temperature 68° - 77° F (20° -  25° C)

Inactive ingredients aloe barbadensis leaf extract, carboxymethyllcellulose

sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene

glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

Questions? 1-800-639-3803 Weekdays 9 AM to 4 PM EST

image description

CVS HEALTH   HEMORRHOIDAL CREAM
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN14.4 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
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69571-010-281 in 1 BOX02/12/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34602/12/2018
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIBusiness Operations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-010)

Revised: 12/2019
Document Id: 99fc1cfa-f606-7822-e053-2995a90aa666
Set id: cb448d78-553c-4e65-80c5-d4b31d7b3661
Version: 2
Effective Time: 20191218
 
FRONT PHARMACEUTICAL PLC