SUNMARK HYDROCORTISONE WITH ALOE  MAXIMUM STRENGTH- hydrocortisone cream 
Central Texas Community Health Centers

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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Sunmark Hydrocortisone with Aloe
Maximum Strength

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

other uses of this product should be only under the advice and supervision of a doctor.

Warnings

Stop using this product and ask a doctor

  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

For External Anal Itching Users

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • children under 12 years of age: consult a doctor

Keep this and all drugs out of the reach of children.

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

Before using any medication, read all label directions. Keep this carton. It contains important information.

Directions

For External Anal Itching Users

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: consult a doctor

Other information

Inactive ingredients

aloe barbadensis, cetostearyl alcohol, citric acid, glycerin, glyceryl stearate, methylparaben, mineral oil, paraffin, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, stearyl alcohol

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

CommUnityCare Federally Qualified Health Centers

HYDROCORTISONE
1% CR 28g

Date:

Name:
Dr.

USE AS DIRECTED.

1/1/01

123456

HYDROCORTISONE 1% CRM 30G NDC 76413-334-28

Batch:
123456
Lot:
123456
Exp:
1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
SUNMARK HYDROCORTISONE WITH ALOE   MAXIMUM STRENGTH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76413-334(NDC:49348-521)
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
aloe vera leaf (UNII: ZY81Z83H0X)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
sodium lauryl sulfate (UNII: 368GB5141J)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76413-334-281 in 1 BOX08/23/1995
128.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/23/1995
Labeler - Central Texas Community Health Centers (079674019)
Establishment
NameAddressID/FEIBusiness Operations
Central Texas Community Health Centers079674019REPACK(76413-334) , RELABEL(76413-334)

Revised: 9/2017
Document Id: e9951e84-d0d0-4561-a9eb-8a052a9bfb1a
Set id: bad20421-85a4-42c2-89db-254c3e2904ef
Version: 1
Effective Time: 20170911
 
Central Texas Community Health Centers