MAKESENSE MAXIMUM STRENGTH- hydrocortisone 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

Hydrocortisone 1%

Purpose

Anti-itch

Uses

■ for temporary relief of itching associated with minor skin irritations and rashes due to: ■ eczema  ■ seborrheic dermatitis ■ psoriasis ■insect bites ■ poison ivy, oak, sumac ■ soaps ■ detergents ■ cosmetics ■ jewelry ■  temporarily relieves external anal and genital itching   ■ other uses of this product should be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

■ in the genital area if you have vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

When using this product

■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not beginuse of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed occurs

Keep out of reach of children

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

Directions

for itching of skin irritation and rashes: ■ adults and children 2 years of age and older: apply to affected
area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

for external anal and genital itching: adults: ■ when practical, clean the affected area with mild soap and water and rinse thoroughly        ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

Other information

■ store at 68-77F (20 to 25C) ■ see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Cetearyl Alcohol, Disodium EDTA, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Sorbitan Stearate, Water

Package Label

Package Label

MAKESENSE  MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-204
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69020-204-1414 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/15/2014
Labeler - Cherry Hill Sales Co (145959768)

Revised: 8/2016
Document Id: 3995a7dc-a245-1eeb-e054-00144ff88e88
Set id: 0559c16d-7422-407f-a4cc-401902a26686
Version: 3
Effective Time: 20160808
 
Cherry Hill Sales Co