family care hemorrhoidal ointment 0.67oz (with applicator) 515

family care hemorrhoidal ointment 0.67oz (with applicator) 515
SPL v13
SPL
SPL Set ID 04375257-f4f3-48c3-a338-de43298b95eb
Route
topical
Published
Effective Date 2014-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
mineral oil (140 mg) petrolatum (749 mg) phenylephrine (2.5 mg)
Inactive Ingredients
glycerin lanolin methylparaben propylparaben stearyl alcohol thyme oil alpha-tocopherol acetate water white wax alcohol polysorbate 80

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-11-24

Description

Active ingredients                                                        Purpose Mineral oil 14%.........................................................Protectant Petrolatum 74.9%.....................................................Protectant Phenylephrine HCl 0.25%...................................Vasoconstrictor


Medication Information

Warnings and Precautions

Warnings For external use only / or intrarectal use only

Active Ingredient

Active ingredients                                                        Purpose

Mineral oil 14%.........................................................Protectant

Petrolatum 74.9%.....................................................Protectant

Phenylephrine HCl 0.25%...................................Vasoconstrictor

Indications and 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 ointment
  • when first opening tube, peel back foil seal
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum
  • thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

Dosage and Administration

Distributed by:

United Exchange Corp

Cypress, CA 90630 USA

Made in China

Description

Active ingredients                                                        Purpose Mineral oil 14%.........................................................Protectant Petrolatum 74.9%.....................................................Protectant Phenylephrine HCl 0.25%...................................Vasoconstrictor

Section 44425-7

Other information

  • store at 20° C to 25°C (68° to 77°F)
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
  • condition gets worse or does not get better within 7 days
  • introduction of applicator into the rectum causes additional pain

Section 50567-7

When using this product do not use more than the recommended daily dosage unless directed by a doctor

Section 50568-5

Ask a doctor or a pharmacist before use if you are now 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
  • difficulty in urination due to enlargement of the prostate gland
  • diabetes
Section 51727-6

Inactive ingredients

.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

Section 51945-4

Section 53414-9

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

Section 55105-1

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieve burning
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful


Structured Label Content

Warnings and Precautions (34071-1)

Warnings For external use only / or intrarectal use only

Active Ingredient (55106-9)

Active ingredients                                                        Purpose

Mineral oil 14%.........................................................Protectant

Petrolatum 74.9%.....................................................Protectant

Phenylephrine HCl 0.25%...................................Vasoconstrictor

Indications and Usage (34067-9)

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 ointment
  • when first opening tube, peel back foil seal
  • apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum
  • thoroughly cleanse applicator after each use and replace cover
  • also apply ointment to external area
  • regular use provides continual therapy for relief of symptoms
  • children under 12 years of age: ask a doctor

Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp

Cypress, CA 90630 USA

Made in China

Section 44425-7 (44425-7)

Other information

  • store at 20° C to 25°C (68° to 77°F)
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
  • condition gets worse or does not get better within 7 days
  • introduction of applicator into the rectum causes additional pain

Section 50567-7 (50567-7)

When using this product do not use more than the recommended daily dosage unless directed by a doctor

Section 50568-5 (50568-5)

Ask a doctor or a pharmacist before use if you are now 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
  • difficulty in urination due to enlargement of the prostate gland
  • diabetes
Section 51727-6 (51727-6)

Inactive ingredients

.alpha.-tocopherol acetate, alcohol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, purified water, white wax

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue and relieve burning
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful


Advanced Ingredient Data


Raw Label Data

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