NDC | 59779-265-61 |
Set ID | 11560597-3b0e-423c-a222-b20bbd98aae9 |
Category | HUMAN OTC DRUG LABEL |
Packager | CVS Pharmacy |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART346 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only.
Ask a doctor before use if you have
- heart disease - high blood pressure - thyroid disease - diabetes
- trouble urinating due to an enlarged prostate gland
Ask a doctor before use if you have
- heart disease
- high blood pressure
- diabetes
- thyroid disease
- 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 depression
When using this product
- do not exceed the recommended daily dosage
- do not put into rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
If pregnant or breast feeding, ask a health professional before use.
Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away -
DOSAGE & ADMINISTRATION
Directions
- adults: when practical, cleanse and gently dry the affected area by patting or blotting with an
appropriate cleansing tissue or soft cloth before applying gel
- when first opening the tube, puncture foil seal with top end of cap
- apply externally to the affected area up to 4 times daily, especially at night,
in the morning or after each bowel movement
- children under 12 years of age: ask a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CVS HEMORRHOIDAL COOLING
witch hazel, phenylephrine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-265 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 500 mg in 1 g PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SULISOBENZONE (UNII: 1W6L629B4K) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) ALOE VERA LEAF (UNII: ZY81Z83H0X) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION) (UNII: ZYD53NBL45) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-265-61 1 in 1 CARTON 1 51 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/18/2010 Labeler - CVS Pharmacy (062312574) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture