Cooling Gel

Cooling Gel
SPL v1
SPL
SPL Set ID 43754077-b819-1a34-e063-6294a90a1712
Route
TOPICAL
Published
Effective Date 2025-11-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (505 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Water Aloe Barbadensis Leaf Methylparaben Edetate Disodium Propylene Glycol Propylparaben Sodium Citrate Sulisobenzone Alpha-tocopherol Acetate Hydroxyethyl Cellulose (140 Mpa.s At 5%) Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-13
Description

Phenylephrine HCl 0.25% Witch Hazel 50.5%

Purpose

Vasoconstrictor Astringent

Medication Information

Purpose

Vasoconstrictor

Astringent

Description

Phenylephrine HCl 0.25% Witch Hazel 50.5%

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • provides temporary relief from irritation and burning
  • temporarily provides a cooling coating for relief of anorectal discomforts
Section 51945-4

Warnings

For External Use Only

Directions
  • Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
  • Gently dry by patting or blotting with a tissue or soft cloth before applying gel
  • When first opening the tube, puncture foil seal with the top end of the cap
  • Apply externally to the affected area up to 4 times daily
  • Children under 12 years of age: Ask a doctor
Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product

Tamper Evident:

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Other Information:

Storage temperature: not to exceed 30°C (86°F). Protect from freezing.

Inactive Ingredients:

Aloe barbadensis leaf extract, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzene, tocopheryl acetate (vitamin E).

Questions Or Comments?

1-877-477-8633

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put in the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a doctor promptly
Stop Use and Ask A Doctor If

condition worsens or does not improve within 7 days

If Pregnant Or Breastfeeding,

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. (1-800-222-1222)

Drug Facts: Active Ingredients

Phenylephrine HCl 0.25%

Witch Hazel 50.5%

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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

Structured Label Content

Uses
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • provides temporary relief from irritation and burning
  • temporarily provides a cooling coating for relief of anorectal discomforts
Section 51945-4 (51945-4)

Purpose

Vasoconstrictor

Astringent

Warnings

For External Use Only

Directions
  • Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
  • Gently dry by patting or blotting with a tissue or soft cloth before applying gel
  • When first opening the tube, puncture foil seal with the top end of the cap
  • Apply externally to the affected area up to 4 times daily
  • Children under 12 years of age: Ask a doctor
Important:

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product

Tamper Evident: (TAMPER EVIDENT:)

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Other Information:

Storage temperature: not to exceed 30°C (86°F). Protect from freezing.

Inactive Ingredients:

Aloe barbadensis leaf extract, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzene, tocopheryl acetate (vitamin E).

Questions Or Comments? (Questions or Comments?)

1-877-477-8633

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put in the rectum by using fingers or any mechanical device or applicator
  • in case of bleeding, consult a doctor promptly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or does not improve within 7 days

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Drug Facts: Active Ingredients

Phenylephrine HCl 0.25%

Witch Hazel 50.5%

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • diabetes
  • thyroid disease
  • 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 (Ask a doctor or pharmacist before use if you are)

presently taking a prescription drug for high blood pressure or depression

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:20.531944 · Updated: 2026-03-14T23:10:41.056891