KERA HC: Package Insert and Label Information

KERA HC- hydrocortisone cream
Clinical Therapeutic Solutions

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.

KERA HC Cream Hydrocortisone 1%

Active Ingredient

Hydrocortisone-USP 1.00%

Purpose

Anti-Itch

Uses:

Temporarily relieves itching associated with minor skin irritations, inflammations and rashes due to:

• Excessively Dry Skin, Eczema, Insect Bites, Poison Ivy, Oak or Sumac, Soaps, Detergents, Cosmetics, Jewelery, Seborrheic Dermatitis, Psoriasis
• Other uses of this product should only be under the advice and supervisor of a doctor

Warnings

• For external use only
  

When using this product:

• Avoid contact with eyes
• Do not use more than directed unless told to do so by a doctor
  

Stop use and ask a doctor if:

• Condition worsens or symptoms persist for more than 7 days, or if symptoms clear up, and then return
  

Keep out of reach of children.

If swallowed, contact physician or poison control center immediately.

Store at room temperature (20-25 degrees C) (68-77 degrees F)

Directions:

For itching of skin irritation, inflammation and rashes:

• Apply to affected area not more than 3 to 4 times daily.
• Not for use by children under 2 years of age

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, c13-14 Isoparaffin, Ethylhexylglycerin, Glycerin, Heilianthus Annuus (Sunflower) Seed Oil, Laureth-7, Phenoxyethanol, Polacrylamide, Polysorbate-20, Tocopheryl Acetate (Vitamin E), Urea-USP.

Distributed By:

Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719 www.CTSRX.com

KERA HC Cream Hydrocortisone 1% 2oz/56g (44577-623-02)

KERA HC hydrocortisone cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44577-623 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF WATER ALKYL (C12-15) BENZOATE C13-14 ISOPARAFFIN ETHYLHEXYLGLYCERIN GLYCERIN SUNFLOWER OIL LAURETH-7 PHENOXYETHANOL POLYSORBATE 20 .ALPHA.-TOCOPHEROL UREA

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:44577-623-02 56 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/17/2012

Labeler — Clinical Therapeutic Solutions (078402750)

Revised: 02/2017 Clinical Therapeutic Solutions