Family Wellness hemorrhoid Max Strength Cream

Family Wellness hemorrhoid Max Strength Cream
SPL v2
SPL
SPL Set ID 16ceb129-5c0a-428a-a867-cfbbb08bb62a
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (144 mg) Phenylephrine (2.5 mg) Pramoxine (10 mg) Petrolatum (150 mg)
Inactive Ingredients
Glyceryl Stearate Se Cetyl Alcohol Stearyl Alcohol Steareth-2 Steareth-21 Carboxymethylcellulose Edetate Disodium Xanthan Gum Sodium Benzoate Tocopherol Methylparaben Light Mineral Oil Propyl Gallate Propylene Glycol Laureth-23 Anhydrous Citric Acid .alpha.-tocopherol Acetate Aloe Vera Leaf Panthenol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-02

Description

Glycerin 14.4% Phenylephrine HCl 0.25%          Pramoxine HCl 1%                    White petrolatum 15%             


Medication Information

Description

Glycerin 14.4% Phenylephrine HCl 0.25%          Pramoxine HCl 1%                    White petrolatum 15%             

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 help make bowel movements less painful
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Pupose 

Protectant

Vasoconstrictor

Local anesthetic

Protectant

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

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

If pregnant or breast-feeding,ask a health professional before use.

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, puncture foil seal with top end of cap
  • 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
Drug Facts 

Active Ingredient 

Glycerin 14.4%

Phenylephrine HCl 0.25%         

Pramoxine HCl 1%                   

White petrolatum 15%             

Other Information 

store at controlled room temperature 68-77°F (20-25°C)

Inactive Ingredients:

Aloe Vera Leaf, Cellulose Gum, Cetyl Alcohol, Citric Acid, Disodium EDTA, Glyceryl Stearate SE, Laureth-23, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Water (purified), Xanthan Gum

Principal Display Panel 

FamilyWellness       NDC 55319-981-25Maxium Strength Hemmorodial Cream NET WT 0.9oz (26g)


Structured Label Content

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 help make bowel movements less painful
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Pupose 

Protectant

Vasoconstrictor

Local anesthetic

Protectant

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

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

If pregnant or breast-feeding,ask a health professional before use.

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, puncture foil seal with top end of cap
  • 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
Drug Facts 

Active Ingredient  (Active ingredient )

Glycerin 14.4%

Phenylephrine HCl 0.25%         

Pramoxine HCl 1%                   

White petrolatum 15%             

Other Information 

store at controlled room temperature 68-77°F (20-25°C)

Inactive Ingredients:

Aloe Vera Leaf, Cellulose Gum, Cetyl Alcohol, Citric Acid, Disodium EDTA, Glyceryl Stearate SE, Laureth-23, Methylparaben, Mineral Oil, Panthenol, Propyl Gallate, Propylene Glycol, Sodium Benzoate, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopherol, Tocopheryl Acetate, Water (purified), Xanthan Gum

Principal Display Panel 

FamilyWellness       NDC 55319-981-25Maxium Strength Hemmorodial Cream NET WT 0.9oz (26g)


Advanced Ingredient Data


Raw Label Data

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