CICATRICURE ULTRA MOISTURIZING- hydrocortisone cream

Cicatricure by

Drug Labeling and Warnings

Cicatricure by is a Otc medication manufactured, distributed, or labeled by Genoma Lab USA Inc, Natureplex LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

• Temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
  • eczema
  • psoriasis
  • jewelry
  • seborrheic dermatitis
• 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
• do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days, and 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 immediately

Directions

• adults and 12 years of age: apply to affected area not more than 3 to 4 times daily
• when practical, clean the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying
• children less than 12 years old: consult a doctor

Other information

• store between 15° - 30°C (59° - 86°F)
• do not use if seal on tube is punctured or missing

Inactive ingredients

Water, stearic acid, cetyl alcohol, mineral oil, glyceryl monostearate, isopropyl alcohol, triethanolamine, carbomer, DMDM hydantoin, polysorbate 20, methyl paraben, trisodium EDTA, propyl paraben, aloe barbadensis (aloe) leaf juice

Questions or comments?

Call toll free 1 877 99 GENOM (43666).
Monday to Friday from 8 am to 6 pm

SPL UNCLASSIFIED SECTION

Distributed by:
Televisa Consumer Products USA, LLC, 4550
Post Oak Place, Suite 326, Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

Cicatricure®

Intensive moisturizer

Helps Relieve Dry, Itchy Skin

NET WT. 1 Oz. (28g)

INGREDIENTS AND APPEARANCE

CICATRICURE   ULTRA MOISTURIZING
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-002
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
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
DMDM HYDANTOIN (UNII: BYR0546TOW)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE TRISODIUM (UNII: 420IP921MB)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-002-01	1 in 1 BOX
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/2013

Labeler - Genoma Lab USA Inc (832323534)

Establishment
Name	Address	ID/FEI	Business Operations
Natureplex LLC		062808196	MANUFACTURE(50066-002)