OLP HEMORRHOIDAL COOLING- phenylephrine hcl, witch hazel gel

OLP HEMORRHOIDAL COOLING by

Drug Labeling and Warnings

OLP HEMORRHOIDAL COOLING by is a Otc medication manufactured, distributed, or labeled by OHIO LAB PHARMA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Phenylephrine HCI, 0.25%

PURPOSE

• Vasoconstrictor
• Astringent

USES

• helps relieve the local itching and discomfort associated with hemorrhoids
• temporary relief of irritation and burning
• temporarily shrinks hemorrhoidal tissue
• aids in protecting irritated anorectal areas

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 this product into the rectum by using fingers or any mechanical device or applicator

STOP USING AND ASK YOUR DOCTOR IF

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

IF PREGNENT OR BREAST-FEEDING

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

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 gel.
• when first opening the tube, puncture foil seal with top end of cap
• apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
• children under 12 years of age: ask a doctor

OTHER INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

QUESTIONS

ohiolabpharma.us

PACKAGE LABEL

COOLING RELIEF
OLP HEMORRHOIDAL COOLING GEL

INGREDIENTS AND APPEARANCE

OLP HEMORRHOIDAL COOLING 
phenylephrine hcl, witch hazel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70648-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	25 mg  in 1 g
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34)	WITCH HAZEL	500 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70648-009-01	1 in 1 CARTON	02/01/2017
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	02/01/2017

Labeler - OHIO LAB PHARMA (080215854)

Registrant - OHIO LAB PHARMA (080215854)

Establishment
Name	Address	ID/FEI	Business Operations
OHIO LAB PHARMA		080215854	manufacture(70648-009)