FDA Label for Signature Care Hemorrhoidal Cream (with Applicator)
View Indications, Usage & Precautions
Signature Care Hemorrhoidal Cream (with Applicator) Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Glycerin 14.4%............................................................Skin protectant
Phenylephrine HCl 0.25%...........................................Vasconstrictor
Pramoxine HCl 1%......................................................Local anesthetic
White petrolatum 15%.................................................Skin protectant
Otc - Purpose
Uses
- for temporary relief of pain, soreness and burning
- helps relieve the local itching and discomfort associated with hemorrhoids
- temporarily shrinks hemorrhoidal tissue
- temporarily provides a coating for relief of anorectal discomforts
- temporarily protects the inflamed, irritated anorectal surface to make bowel movements less painful
Warnings
Warnings
For external and/or intrarectal use only
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- difficult in urination due to enlargement of the prostate gland
- diabetes
Otc - When Using
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens or does not improve within 7 days
- bleeding occurs
- an allergic reaction develops
- the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
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 first opening the tube, peel back foil seal
- apply externally or in the lower portion of the anal canal only
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus
- thoroughly cleanse dispensing cap after each use and replace cover
- children under 12 years of age: ask a doctor
Storage And Handling
Other information
- store at room temperature 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients
.alpha.-tocopherol acetate, aloe vera leaf, anhydrous lanolin, butylated hydroxytoluene, cetostearyl alcohol, cetyl esters wax, cetyl palmitate, glycryl monostearate, isopropyl myristate, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, steareth-20, stearic acid, trisodium citrate dihydrate
Dosage & Administration
Distributed by:
Better Living Brands LLC
Made in China
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