OTC Medication Information: CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL

CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL- phenylephrine hydrochloride and witch hazel gel
CVS

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 Facts

Active ingredients Purpose
Hamamelis virginiana (witch hazel) 50% Astringent
Phenylephrine hydrochloride 0.25% Vasoconstrictor

Uses

  • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
  • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas
  • temporary relief of burning

Warnings

For external use only.

Do not use this product

  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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 recommended daily dosage unless directed by a doctor
  • do not put into rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs

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: 800-222-1222.

Directions

Adults

  • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
  • apply externally to affected area up to 4 times daily or after each bowel movement

Children under 12 years old: Ask a doctor.

Other information

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions or comments?

866-323-0107

Distributed by: CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL — 26 g Tube Carton

CVS
Health®

Compare to the active
ingredients in Preparation H®
Cooling Gel*

NDC 69842-843-01

Hemorrhoidal
Cooling Gel

FAST COOLING RELIEF

  • Clear, non-greasy formula
    with soothing aloe & a
    pleasant scent
  • Shrinks swollen
    hemorrhoidal tissue
  • Prompt cooling relief from
    painful burning & itching
  • Relieves external discomfort

Package Contains
One Tube

NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL -- 26 g Tube Carton
(click image for full-size original)
CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL
phenylephrine hydrochloride and witch hazel gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-843
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 1 g
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 500 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
SULISOBENZONE
EDETATE DISODIUM ANHYDROUS
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE, UNSPECIFIED FORM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69842-843-01 1 TUBE in 1 CARTON contains a TUBE
1 26 g in 1 TUBE This package is contained within the CARTON (69842-843-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 01/01/2004
Labeler — CVS (062312574)
Establishment
Name Address ID/FEI Operations
Natureplex LLC 062808196 MANUFACTURE (69842-843)

Revised: 11/2022 CVS

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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