MAKESENSE- phenylephrine hydrochloride zinc oxide cream

MAKESENSE by

Drug Labeling and Warnings

MAKESENSE by is a Otc medication manufactured, distributed, or labeled by Cherry Hill Sales Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Phenylephrine HCL 0.25%

Zinc Oxide 12.50%

Purpose

Vasoconstrictor

Astringent

Uses

For temporary relief of local anorectal burning and discomfort associated with hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.

Warnings

For external use only

Do not use

■ on children under 2 years of age except under the advise and supervision of a doctor ■ for diaper rash

Stop use and ask a doctor if

■ condition worsens or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ Do not exceed the recomended daily dosage unless directed by a doctor ■ In case of bleeding, consult a doctor promptly ■ Certain persons can develop allergic reactions to ingredients in this product ■ If the symptom treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult doctor ■ If you are pregnant, do not use this product without first consulting doctor.

Keep out of reach of children

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

Directions

■ Cleanse affected area with mild soap and warm water, rinse thorouhly ■ Dry by patting or blotting with toilet tissue
or soft cloth before applying ■ Cover the entire affected area with a thin layer 1 to 3 times daily ■ Children under 12 years of age need
to consult doctor before using this product

Other information

■ store at 68-77F (20 to 25C) ■ See Lot No. and Exp. Date: on box and crimp of tube

Inactive Ingredients

Lanolin, Methylparaben, Ozokerite, Paraffin, Propylparaben, White Petrolatum

Package Label

INGREDIENTS AND APPEARANCE

MAKESENSE 
phenylephrine hydrochloride zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69020-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	12.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69020-205-28	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	07/31/2014

Labeler - Cherry Hill Sales Co (145959768)