MAKESENSE - phenylephrine hydrochloride zinc oxide cream 
Cherry Hill Sales Co

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

image description

MAKESENSE 
phenylephrine hydrochloride zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERESIN (UNII: Q1LS2UJO3A)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69020-205-2828 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/31/2014
Labeler - Cherry Hill Sales Co (145959768)

Revised: 8/2014
Document Id: 08a315bb-41c8-4cc9-9754-ec3b3bb5e7d7
Set id: 2d69b75e-55e0-49f5-8646-8befcc941b0a
Version: 1
Effective Time: 20140811
 
Cherry Hill Sales Co