Hemaway Maximum Strength Hemorrhoid Relief Cream

Hemaway Maximum Strength Hemorrhoid Relief Cream
SPL v3
SPL
SPL Set ID cf842adf-fcd7-2c8c-e053-2995a90adea6
Route
TOPICAL
Published
Effective Date 2020-08-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (1.5 g)
Inactive Ingredients
Benzyl Alcohol Carbomer Homopolymer Type C Cholesterol Hydrogenated Soybean Lecithin Isopropyl Myristate Polysorbate 80 Propylene Glycol Water Trolamine Alpha-tocopherol Acetate Grape Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-04

Description

Uses Temporarily relieves pain, itching and discomfort due to anorectal disorders.


Medication Information

Warnings and Precautions

Warnings

For External use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product.

Indications and Usage

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders.

Dosage and Administration

Directions

  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
  • Children under 12 years of age: consult a doctor.

Description

Uses Temporarily relieves pain, itching and discomfort due to anorectal disorders.

Section 50565-1

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

Section 50566-9

Stop use and ask a Doctor if:

  • Rectal bleeding occurs
  • Conditions worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Symptoms clear up and return in a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase
Section 50567-7

When using this product:

  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
Section 50568-5

Ask a Doctor or Pharmacist if you are: Presently taking a prescription drug for high blood pressure or depression.

Section 50569-3

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
Section 51727-6

Inactive ingredients: Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

Section 51945-4

Section 53413-1

Other information

  • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
  • Tamper-Evident: do not use if foil seal under cap is broken or missing.
  • See crimp of tube for lot number and expiration date.

Section 53414-9

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

Section 55105-1

Local anesthetic

Section 55106-9

Active Ingredients



Lidocaine 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves pain, itching and discomfort due to anorectal disorders.

Dosage and Administration (34068-7)

Directions

  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.
  • Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For External use only

Allergy alert: Certain persons can develop allergic reactions to ingredients in this product.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a Doctor if:

  • Rectal bleeding occurs
  • Conditions worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Symptoms clear up and return in a few days
  • Redness, irritation, swelling, pain or other symptoms begin or increase
Section 50567-7 (50567-7)

When using this product:

  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
Section 50568-5 (50568-5)

Ask a Doctor or Pharmacist if you are: Presently taking a prescription drug for high blood pressure or depression.

Section 50569-3 (50569-3)

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
Section 51727-6 (51727-6)

Inactive ingredients: Aloe Barbadensis Leaf Juice Extract, Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, vitamin E Acetate, Vitis Vinifera (Grape) Skin Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Other information

  • To secure child-resistant cap: screw cap tightly. Then turn cap in opposite direction. If clicking sound is not heard, repeat procedure.
  • Tamper-Evident: do not use if foil seal under cap is broken or missing.
  • See crimp of tube for lot number and expiration date.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Local anesthetic

Section 55106-9 (55106-9)

Active Ingredients



Lidocaine 5%


Advanced Ingredient Data


Raw Label Data

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