THERAPLEX AIM ANTI-ITCH MOISTURIZING- hydrocortisone cream

THERAPLEX AIM Anti-Itch Moisturizing by

Drug Labeling and Warnings

THERAPLEX AIM Anti-Itch Moisturizing by is a Otc medication manufactured, distributed, or labeled by THERAPLEX, 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

Package Labeling 2oz:

Package Labeling 3oz:

INGREDIENTS AND APPEARANCE

THERAPLEX AIM ANTI-ITCH MOISTURIZING 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82280-478
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 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: 82280-478-02	56.7 g in 1 JAR; Type 0: Not a Combination Product	05/06/2024
2	NDC: 82280-478-03	85 g in 1 JAR; Type 0: Not a Combination Product	05/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/06/2024

Labeler - THERAPLEX, LLC (118005210)