Label: CVS HEALTH HEMORRHOIDAL CREAM- glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream
- NDC Code(s): 69571-010-28
- Packager: FRONT PHARMACEUTICAL PLC
- 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 December 18, 2019
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- ACTIVE INGREDIENT
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
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
DOSAGE & ADMINISTRATION
•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
- INACTIVE INGREDIENT
- 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)