THERAPLEX AIM ANTI-ITCH MOISTURIZING CREAM- hydrocortisone cream 
The Theraplex Company, LLC

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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Theraplex® AIM Anti-Itch Moisturizing Cream

Drug Facts

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
•eczema •soaps •detergents •cosmetics •seborrheic dermatitis •psoriasis. •Other uses of this product should only be 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, symptoms persist more than 7 days, or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have asked 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: apply to affected area not more than 3 to 4 times daily.
• Children under 2 years of age: do not use, ask a doctor.

Inactive Ingredients

Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

Other information

• Store at 20° to 25°C (68° to 77°F)

Questions?

• Toll-free number 888-437-2753 • For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

NON STINGING

For Maximum Strength Relief of Rashes & Itching Flare-Ups Caused by
• Eczema • Psoriasis • Seborrheic Dermatitis

NEW

Stops the itch of Eczema quickly

• Helps repair and restore the skin’s natural protective barrier

• Promotes healthy skin flora

• Contains natural coconut oil to soothe and moisturize the skin

• Instantly penetrates into the skin's surface

• NO preservatives, parabens, fragrances, lanolin, or gluten

• Not tested on animals

• Non-stinging

• Patent Pending

www.theraplex.com

Dist. By The Theraplex Company, LLC, Memphis, TN 38119

Packaging

Therplx3

THERAPLEX  AIM ANTI-ITCH MOISTURIZING CREAM
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62917-819
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
PETROLATUM (UNII: 4T6H12BN9U)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
COCONUT OIL (UNII: Q9L0O73W7L)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
FERULIC ACID (UNII: AVM951ZWST)  
OATMEAL (UNII: 8PI54V663Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62917-819-031 in 1 CARTON08/15/2019
185 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/15/2019
Labeler - The Theraplex Company, LLC (363529392)

Revised: 6/2019
Document Id: f3209799-1843-4271-bf8d-1c833a00d644
Set id: ff735ed1-10da-4fa2-b342-fd11eeec9059
Version: 1
Effective Time: 20190617
 
The Theraplex Company, LLC