SPL v3
SPL
SPL Set ID fde9cd90-d63c-4058-b46e-511fecea36ec
Route
TOPICAL
Published
Effective Date 2016-07-14
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 2016-07-14

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

-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

Ask a doctor before use if you have

-heart disease  -high blood pressure  -thyroid disease  -diabetes

-trouble urinating due to an enlarged prostate gland

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

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 if 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

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. Gently dry 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 or -

in the morningor after each bowel movement.

Children 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. Gently dry 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 or -

in the morningor after each bowel movement.

Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product

-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

Ask a doctor before use if you have

-heart disease  -high blood pressure  -thyroid disease  -diabetes

-trouble urinating due to an enlarged prostate gland

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

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 if 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

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

All Sections (JSON)