TECNU CORTICOOL- hydrocortisone gel 
Tec Laboratories, Inc.

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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Active Ingredient 
Hydrocortisone 1%

Purpose

Anti-itch

Uses

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

•poison oak/ivy/sumac   •eczema   •insect bites  •soaps 

•detergents  •psoriasis  •cosmetics  •jewelry  

•seborrheic dermatitis

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

Warnings
For external use only

​Do not use:

•for the treatment of diaper rash; consult a doctor

When using this product
•avoid contact with eyes

Stop use 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, do not use this or any other hydrocortisone unless directed by 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 of age and older:
    •cleanse skin with soap and water, then dry the affected area
    •apply to affected area not more that 3 to 4 times daily; rub thoroughly into skin

Children under 2 years of age:
    ■do not use; consult a doctor

Other information: Store at 59° to 86° F (15° to 30° C)

Inactive ingredients

hypromellose, menthol, polyoxyl 35 castor oil, propylene glycol, purified water, SD alcohol 40-B (20% by weight)

Questions? Call 1-800-ITCHING
Serious side effects may be reported to this number

Tube display carton

Soothing, long-lasting relief

NDC: 51879-110-15

OUTDOOR SOLUTIONS SINCE 1962™

tecnu®

Corticool®

1.0%

Hydrocortisone

Anti-Itch Gel

Instant Absorbing Itch Relief

Cooling

50% MORE than 1 oz.

  • Eczema & Psoriasis
  • Insect bites
  • Inflammation & Redness
  • Poison ivy & oak
  • Pollen & other minor rashes

MAXIMUM STRENGTH

NET WT. 1.5 OZ. (42.53g)

Corticool tube point of purchase carton

Packet dispenser carton

NDC 51879-110-44

OUTDOOR SOLUTIONS SINCE 1962

tecnu®

Corticool®

1.0% Hydrocortisone Gel

MAXIMUM STRENGTH

Instant Absorbing Itch Relief

144 PACKETS

NET WT 1/32 OZ.

(0.89 g) PER PACKET

Corticool packet dispenser carton

TECNU CORTICOOL 
hydrocortisone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-110
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
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
MENTHOL (UNII: L7T10EIP3A)  
POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51879-110-151 in 1 CARTON06/23/199904/03/2017
142.53 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51879-110-44144 in 1 CARTON06/23/199904/03/2017
2NDC:51879-110-320.89 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/23/199904/03/2017
Labeler - Tec Laboratories, Inc. (083647792)
Establishment
NameAddressID/FEIBusiness Operations
Tec Laboratories, Inc.083647792manufacture(51879-110)

Revised: 11/2017
 
Tec Laboratories, Inc.