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

CVS Health by

Drug Labeling and Warnings

CVS Health by is a Otc medication manufactured, distributed, or labeled by FRONT PHARMACEUTICAL PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

PURPOSE

Purpose

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

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

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

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

INDICATIONS & USAGE

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

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

Keep out of reach of children. If swallowed, get medical help or contact

a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS HEALTH   HEMORRHOIDAL CREAM
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-010
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
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
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-010-28	1 in 1 BOX	02/12/2018
1		28 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 final	part346	02/12/2018

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-010)