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REXALL HEMORRHOIDAL COOLING by Dolgencorp, Inc.

Medically reviewed on July 13, 2017

Dosage form: gel
Ingredients: PHENYLEPHRINE HYDROCHLORIDE 0.25g in 100g, WITCH HAZEL 50g in 100g
Labeler: Dolgencorp, Inc.
NDC Code: 55910-416

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.

REXALL HEMORRHOIDAL COOLING GEL

Active Ingredients

Phenylephrine Hydrochloride  0.25%
Witch Hazel   50%

Purpose

Vasoconstrictor
Astringent

Uses
  • temporary relieves irritation and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas

Warnings

For external use only

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 this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • bleeding occurs
  • condition gets worse or does not improve within 7 days

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 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

Other information
  • store at 20°-25°C (68°-77°F)
  • for lot number and expiration date, see crimp of tube or see box

Inactive ingredients

aloe barbadensis leaf juice, disodium EDTA, hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, tocopheryl acetate (Vitamin E)

Principal display panel - 26 g Carton Label

REXALL HEMORRHOIDAL COOLING GEL

NET WT .9 OZ (26 g)

REXALL HEMORRHOIDAL COOLING 
phenylephrine hydrochloride and witch hazel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-416
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE0.25 g  in 100 g
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL50 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
EDETATE DISODIUM 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SODIUM CITRATE 
.ALPHA.-TOCOPHEROL 
Packaging
#Item CodePackage Description
1NDC:55910-416-2626 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/12/2017
Labeler - Dolgencorp, Inc. (068331990)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIOperations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-416)

 
Dolgencorp, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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