THERAPLEX AIM ANTI-ITCH MOISTURIZING CREAM- hydrocortisone cream

Theraplex by

Drug Labeling and Warnings

Theraplex by is a Otc medication manufactured, distributed, or labeled by The Theraplex Company, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

THERAPLEX  AIM ANTI-ITCH MOISTURIZING CREAM
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62917-819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
CYCLOMETHICONE (UNII: NMQ347994Z)
COCONUT OIL (UNII: Q9L0O73W7L)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
FERULIC ACID (UNII: AVM951ZWST)
OATMEAL (UNII: 8PI54V663Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62917-819-03	1 in 1 CARTON	08/15/2019
1		85 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/15/2019

Labeler - The Theraplex Company, LLC (363529392)