Label: REXALL HEMORRHOIDAL COOLING- witch hazel, phenylephrine hydrochloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-603-61 - Packager: DOLLAR GENERAL
- 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.
Drug Label Information
Updated November 18, 2010
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Uses
- temporarily relieves irritation and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- aids in protecting irritated anorectal areas
Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)
- for lot number and expiration date, see crimp of tube or see box
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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
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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
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INGREDIENTS AND APPEARANCE
REXALL HEMORRHOIDAL COOLING
witch hazel, phenylephrine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-603 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 AT 1%) (UNII: ZYD53NBL45) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-603-61 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 - DOLLAR GENERAL (068331990) Registrant - Pharma Pac, LLC (140807475) Establishment Name Address ID/FEI Business Operations Pharma Pac, LLC 140807475 manufacture