SPL v6
SPL
SPL Set ID eb1785f4-5876-443b-b175-9b59d65d1a48
Route
TOPICAL
Published
Effective Date 2017-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (14.4 g) Phenylephrine (0.25 g) Pramoxine (1 g) Petrolatum (15 g)
Inactive Ingredients
Aloe Vera Leaf Carboxymethylcellulose Sodium Cetyl Alcohol Glyceryl Monostearate Paraffin Methylparaben Propylene Glycol Propylparaben Water Xanthan Gum Stearic Acid Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-14

Description

Active ingredients (in each gram) Glycerin 14.4% Phenylephrine HCL 0.25% Pramoxine HCL 1% White petrolatum 15%


Medication Information

Warnings and Precautions

Warnings

. For external use only

When using this product

Ask a doctor before use if you have

•heart disease  •high blood pressure  •thyroid disease  •diabetes

•trouble urinating due to an enlarged prostate gland

you are presently taking a prescription Ask a doctor or pharmacist before use if

drug for high blood pressure.

Stop use and ask a doctor if

•bleeding occurs  •condition worsens or does not improve within 7 days

-if the symptoms being treated do not subside or ir redness, irritation, swelling,

pain or other symptoms develop or increase. Some people can develop allergic

reactions to ingredients in this product.

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

  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor
Indications and Usage

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
Dosage and Administration

Adults: Directions

-when practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gentlydry by patting or blotting with toilet tissue or a soft

cloth before application of this product.

-apply externally to the affected area up to 4 times daily especially at night r

in the morningor after each bowel movement.

hildren under 12 years of age: consult a doctor.

Description

Active ingredients (in each gram) Glycerin 14.4% Phenylephrine HCL 0.25% Pramoxine HCL 1% White petrolatum 15%

Section 44425-7

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

Section 50565-1

. If swallowed, get medical help or contact a Keep out of reach of children

Poison Control Center right away.

Section 51727-6

aloe barbadensis leaf extract, Inactive ingredients

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

Section 51945-4

Section 55105-1

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Section 55106-9

Active ingredients (in each gram)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL 1%

White petrolatum 15%


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Adults: Directions

-when practical, cleanse the affected area with mild soap and warm water and

rinse thoroughly. Gentlydry by patting or blotting with toilet tissue or a soft

cloth before application of this product.

-apply externally to the affected area up to 4 times daily especially at night r

in the morningor after each bowel movement.

hildren under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

. For external use only

When using this product

Ask a doctor before use if you have

•heart disease  •high blood pressure  •thyroid disease  •diabetes

•trouble urinating due to an enlarged prostate gland

you are presently taking a prescription Ask a doctor or pharmacist before use if

drug for high blood pressure.

Stop use and ask a doctor if

•bleeding occurs  •condition worsens or does not improve within 7 days

-if the symptoms being treated do not subside or ir redness, irritation, swelling,

pain or other symptoms develop or increase. Some people can develop allergic

reactions to ingredients in this product.

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

  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor
Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

. If swallowed, get medical help or contact a Keep out of reach of children

Poison Control Center right away.

Section 51727-6 (51727-6)

aloe barbadensis leaf extract, Inactive ingredients

carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate,

methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80,

water, xanthan gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Section 55106-9 (55106-9)

Active ingredients (in each gram)

Glycerin 14.4%

Phenylephrine HCL 0.25%

Pramoxine HCL 1%

White petrolatum 15%


Advanced Ingredient Data


Raw Label Data

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