DRS. HYDROCORTISONE ALOE VERA- hydrocortisone cream 
OL PHARMA TECH,LLC

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ACTIVE INGREDIENT

Hydrocortisone, USP 1%

PURPOSE

Anti-itch


USES

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

•eczema

•insect bites

•poison ivy

•poison oak

•poison ...

WARNINGS

For external use only


DO NOT USE

for external feminine itching if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

WHEN USING THIS PRODUCT

•avoid contact with the eyes

•do not begin the use of any other hydrocortisone product unless directed by a doctor

•for external anal itching:

do not use more than directed unless directed by a doctor

do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE AND ASK YOUR DOCTOR IF

•symptoms last for more than 7 days

•the condition gets worse

•symptoms clear up and occur again in a few days

•rectal bleeding occurs, consult doctor promptly

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.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E, Aloe vera leaf.

aloe vera

DRS. HYDROCORTISONE ALOE VERA 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-088
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETEARETH-12 (UNII: 7V4MR24V5P)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MINERAL OIL (UNII: T5L8T28FGP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80489-088-011 in 1 CARTON01/01/2021
128.3 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:80489-088-021 in 1 CARTON01/01/2021
249.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01601/01/2021
Labeler - OL PHARMA TECH,LLC (021170377)
Registrant - OL PHARMA TECH,LLC (021170377)
Establishment
NameAddressID/FEIBusiness Operations
OL PHARMA TECH,LLC (Drs. pharmacy)021170377manufacture(80489-088)

Revised: 1/2024
Document Id: 0df0642f-1b0a-1bd9-e063-6294a90a72df
Set id: 0df06415-5d32-7ef8-e063-6294a90a6e5a
Version: 1
Effective Time: 20240102
 
OL PHARMA TECH,LLC