HYDROCORTISONE CREAM 1%- hydrocortisone cream 1% cream 
SOLA Pharmaceuticals

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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Hydrocortisone Cream 1%

Active Ingredient

Hydrocortisone 1%

Purpose

Antipruritic (Anti-itch)

Uses

Relieves itches and rashes due to:

Temporary relief of external anal and genital itching.

Other use of the product should only be under the advice and supervision of a doctor.

Warnings

For external use only

Do not use:

Ask doctor before use:

Stop use and ask a doctor if:

​When using this product:

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

Directions

Other Information

Inactive Ingredients

Cetomacrogol 1000, Cetostearyl alcohol, Chlorocresol, Disodium EDTA, Liquid paraffin, Propylene glycol, Purified water, Sodium metabisulphite, White soft paraffin.

Questions of comments? Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810


Store in a dry, cool place

Hydrocortisone 1% Cream

NDC 70512-101-30


Qty: 28.4g

Hydrocortisone boxHydrocortisone Tube

HYDROCORTISONE CREAM 1% 
hydrocortisone cream 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-101
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
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETETH-20 (UNII: I835H2IHHX)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70512-101-301 in 1 CARTON04/16/2020
130 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 finalpart34804/16/2020
Labeler - SOLA Pharmaceuticals (080121345)

Revised: 7/2022
Document Id: e314cc52-3f73-9a9c-e053-2a95a90a3f4a
Set id: a36b9275-fc3f-106a-e053-2a95a90a3beb
Version: 4
Effective Time: 20220705
 
SOLA Pharmaceuticals