KERA HC- hydrocortisone cream

KERA HC by

Drug Labeling and Warnings

KERA HC by is a Otc medication manufactured, distributed, or labeled by Clinical Therapeutic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

KERA HC 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44577-623
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44577-623-02	56 g in 1 TUBE; Type 0: Not a Combination Product	02/06/2017

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)