CICATRIX SKIN PROTECTANT- glycerin cream

Cicatrix Skin Protectant by

Drug Labeling and Warnings

Cicatrix Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Catalysis, SL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS PURPOSE

Glycerin 3%.................... Skin Protectant

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep our of the eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children

Children under 6 months: as a doctor.

WARNINGS

Stop use and ask a doctor if rash occurs

Children under 6 months: ask a doctor

Warnings

Keep out of reach of children

Questions or comments?

+ 34 M-F 9:00 am to 5:00 pm

Other Information

. keep the product in a cool and dry place

Directions

. clean and dry the affected area.

. apply the product and massage the affected area

. follow the instructions on the insert

. apply at least twice a day

• clean and dry the affected area.
• apply the product and massage the affected area
• follow the instructions on the insert
• apply at least twice a day

Uses

. helps to reduce the scars and marks in t he skin

Inactive Ingredients

Aqua, Cyclopentasiloxane, Cetearyl Alcohol, PPG-11 Stearyl Ether, Steareth-2, Ceramide 3, Ceramide 6II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Centella Asiatica Leaf Extract, Maltodextrin, Stearic Acid, Palmitic Acid, Phenoxyethanol, Ethylhexylglycerin, C12-C15 Alkyl Benzoate, Steareth-20, Pinus Sylvestris Bud Extract, Sodium Benzoate, Potassium Sorbate, Sodium Hyaluronate, Carbomer, Diazolydinil Urea, Parfum( coumarin, hexyl cinnamal,linalool,d-limonene/dipentene/l-limonene,Geraniol,hydroxycitronellal), Sodium Hydroxide

Uses

• helps to reduce the scars and marks in t he skin

Package Label

INGREDIENTS AND APPEARANCE

CICATRIX SKIN PROTECTANT 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64539-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COUMARIN (UNII: A4VZ22K1WT)	0.1 mg  in 1 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.2 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.12 mg  in 1 mL
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)	0.12 mg  in 1 mL
PPG-11 STEARYL ETHER (UNII: S4G2J0Y0LG)	3 mg  in 1 mL
STEARETH-2 (UNII: V56DFE46J5)	2.4 mg  in 1 mL
CERAMIDE 3 (UNII: 4370DF050B)	0.25 mg  in 1 mL
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)	0.25 mg  in 1 mL
CERAMIDE 6 II (UNII: F1X8L2B00J)	0.25 mg  in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J)	0.25 mg  in 1 mL
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)	0.25 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	100 mg  in 1 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)	0.45 mg  in 1 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.25 mg  in 1 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)	3 mg  in 1 mL
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)	0.8 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.07 mg  in 1 mL
STEARETH-20 (UNII: L0Q8IK9E08)	0.6 mg  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU)	0.14 mg  in 1 mL
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	7 mg  in 1 mL
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)	0.2 mg  in 1 mL
MALTODEXTRIN (UNII: 7CVR7L4A2D)	0.5 mg  in 1 mL
PALMITIC ACID (UNII: 2V16EO95H1)	0.5 mg  in 1 mL
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)	0.5 mg  in 1 mL
STEARIC ACID (UNII: 4ELV7Z65AP)	0.5 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.5 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.5 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64539-011-02	1 in 1 BOX	02/03/2018
1	NDC: 64539-011-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/28/2018

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Establishment
Name	Address	ID/FEI	Business Operations
Catalysis, SL		862795119	manufacture(64539-011)