ACTIVE INGREDIENTS PURPOSE

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

Bottle

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

Cicatrix

CICATRIX SKIN PROTECTANT
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:64539-005
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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
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
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:64539-005-02	1 in 1 BOX	05/02/2017
1	NDC:64539-005-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	05/02/2017

Labeler - Catalysis, SL (862795119)

Registrant - Catalysis, SL (862795119)

Name	Address	ID/FEI	Business Operations
Establishment
Catalysis, SL		862795119	manufacture(64539-005)