CAREALL HEMORRHOIDAL- mineral oil, petrolatum, phenylephrine hcl ointment

CAREALL Hemorrhoidal by

Drug Labeling and Warnings

CAREALL Hemorrhoidal by is a Otc medication manufactured, distributed, or labeled by New World Imports, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purpose

Active Ingredients Purposes
Mineral Oil 14%...................................................................Protectant
Petrolatum 74.9%................................................................Protectant
Phenylephrine HCl 0.25%...............................................Vasoconstrictor

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Uses

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

Warnings

For external and/or intrarectal 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
Stop use and ask a doctor if
▪ bleeding occurs ▪ condition worsens or does not improved within 7 days
▪ introduction of applicator into the rectum causes additional pain
If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toliet tissue or a soft cloth before applying ointment

• 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
• EXTERNAL USE: apply to affected area
• Apply to affected areas up to 4 times daily

Children under 12 years of age: consult a doctor

Inactive Ingredients

Benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, Vitamin E, white wax

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAREALL HEMORRHOIDAL 
mineral oil, petrolatum, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51824-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	140 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	749 mg  in 1 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	2.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CORN OIL (UNII: 8470G57WFM)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
THYME OIL (UNII: 2UK410MY6B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE WAX (UNII: 7G1J5DA97F)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51824-079-02	56 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	01/01/2020

Labeler - New World Imports, Inc (075372276)