Drug Facts Active Ingredients
Phenylephrine HCl 0.25%
Witch Hazel 50%
Cooling Gel
FDA Label NDC 13709-354
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Cooling Gel (NDC 13709-354). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts active ingredients, purpose, uses, warnings, ask a doctor before use if you have, if pregnant or breastfeeding,, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Phenylephrine HCl 0.25% .......................................................................Vasoconstrictor
Witch Hazel 50%. ............................................................................................Astringent
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
Warnings
For external use only
Ask A Doctor Before Use If You Have
- Heart disease
- High blood pressure
- Thyroid disease
- Diabetes
- Difficulty in urination due to enlargement of prostate gland unless directed by a doctor
If Pregnant Or Breastfeeding,
ask a health professional before use.
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 unless directed by a doctor
- do not put in the rectum by using fi ngers or any mechanical device or applicator
- in case of bleeding, consult a doctor promptly.
Stop Use And Ask A Doctor If
Bleeding occurs
- Condition worsens or does not improve within 7 days.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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 a soft cloth before applying cream
- When fi rst opening the tube, puncture foil seal with top end of cap
- Apply externally to the affected area up to 4 times daily
- Children under 12 years of age: ask a doctor
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, Purifi ed Water, Sodium Citrate, Sulisobenzone, Vitamin E Acetate.
Questions Or Comments?
1 (877) 477-8633
Tamper Evident:
DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
Important:
Please do not discard this printed box and any enclosed printed material. The inside fi nal product may not have all the details you require for the ongoing use of the product.
Package Label
Tube (Pk Tu082 Rev1 Coolinggel 1oz Tube V6 Page 0001)
Box (Pk Ic121 Rev1 Coolinggel 1oz Box V2 Page 0001)
* Please review the disclaimer below.
