HYDROCORTISONE  - hydrocortisone liquid 
CVS Pharmacy

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                            Purpose


Hydrocortisone 1%...................................External analgesic




Active ingredient                            Purpose

Hydrocortisone 1%...................................External analgesic

Uses Temporarily relieves itching associated with minor skin
irritation and rashes due to saborrheic dermatitis and psoriasis.
Other uses of this product should be only used under the advice
and supervision of a doctor.


Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.




Directions 

- adults and children 2 years and older: apply to affected areas one to four times daily

- children under 2 years of age, do not use, consult a doctor

Warnings

For external use only.

When using this product

- do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

Stop use of this product and do not begin use of any other hydrocortisone product if

- condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, unless you have consulted a doctor.

Keep out of reach of children. If swallowed, get medical
help or contact a Poison Control Center right away.

Flammable, Keep away from fire or flame.



Directions

- adults and children 2 years and older: apply to affected areas one to four times daily

- children under 2 years of age, do not use, consult a doctor



Inactive Ingredients SD Alcohol 40-B, water, propylene glycol, menthol, tocopheryl acetate,
aloe barbadensis leaf juice, meialeuce alternilolia (tea tree) leaf oil, disodium EDTA


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HYDROCORTISONE  
hydrocortisone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
MENTHOL (UNII: L7T10EIP3A)  
TEA TREE OIL (UNII: VIF565UC2G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-318-031 in 1 CARTON
144 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34807/16/2010
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2010
Document Id: a4afd246-11e9-4aef-9a22-ec9d38142e7a
Set id: 0d72f26d-304c-4541-844a-76865f7c7fc5
Version: 1
Effective Time: 20100716
 
CVS Pharmacy