FLUIDBASE MAX by LABORATORIO GENOVE S.A. FLUIDBASE MAX

FLUIDBASE MAX by

Drug Labeling and Warnings

FLUIDBASE MAX by is a Otc medication manufactured, distributed, or labeled by LABORATORIO GENOVE S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLUIDBASE MAX- glycerin cream 
LABORATORIO GENOVE S.A.

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.

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FLUIDBASE MAX

ACTIVE INGREDIENTS

ACTIVE INGREDIENT PURPOSE

Glycerin 10.5%..........................................................Skin protectant

Mineral Oil 5%...........................................................Skin protectant

USES

• Helps prevents and protects against of sun damage
• Helps to combat the signs of ageing

USES

• Helps prevents and protects against of sun damage
• Helps to combat the signs of ageing

WARNINGS

• FOR EXTERNAL USE ONLY
• Do not use on damaged or broken skin
• Stop use and Ask a Doctor if rash occurs;
• Keep out of reach of children
• Children under 6 months: ask a Doctor

WARNINGS

• Stop use and Ask a Doctor if rash occurs;

WARNINGS

• Do not use on damaged or broken skin

WARNINGS

• Stop use and Ask a Doctor if rash occurs;

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: in case of overdose

get medical help or Contact a Poison Control Center

right away.

When using this product

• Avoid contact with eyes

DIRECTIONS

• Apply twice a day around the eyes, forehead

and another areas affected by expression lines

such as the borders of the corners of the mouth

INDICATIONS

• Apply twice a day around the eyes, forehead

and another areas affected by expression lines

such as the borders of the corners of the mouth

OTHER INFORMATION

• Keep the product in a cool and dry place

INACTIVE INGREDIENTS

water, acetyl octapeptide-3, leucine, caprylyl glycol, hydrolyzed soy protein, hydrolyzed wheat protein, butylene glycol, xanthan gum, glycyl-isolysine, carbomer, avobenzone, phenoxyethanol, methylparaben, butylparaben, ethylparaben, propylparaben, parfum, citral, hydroxyisohexyl -3- cyclohexene carboxaldehyde, linalool, limonene, citronellol, isomethyl-alpha- ionone, geraniol, hyaluronate sodium, sodium hydroxide

QUESTIONS AND COMMENTS:

+ 1 267- 687 8694

FLUIDBASE MAX

FLUIDBASE MAX

WRINKLE RELAX SYSTEM CREAM +

DNA PROTECTOR

SKIN PROTECTANT

FLUIDBASE MAX 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70963-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	10.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCYL-ISOLYSINE (UNII: O12PZI77AL)	0.0033 mg  in 1 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	0.8 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.62 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX)	0.5 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	100 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP)	5 mg  in 1 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.16 mg  in 1 mL
GERANIOL (UNII: L837108USY)	0.002451 mg  in 1 mL
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)	0.011733 mg  in 1 mL
LEUCINE (UNII: GMW67QNF9C)	0.0025 mg  in 1 mL
ACETYL OCTAPEPTIDE-3 (UNII: 8K14HJF88S)	0.00275 mg  in 1 mL
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)	0.19 mg  in 1 mL
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)	0.11 mg  in 1 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	0.396 mg  in 1 mL
XANTHAN GUM (UNII: TTV12P4NEE)	0.0528 mg  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T)	0.1 mg  in 1 mL
BUTYLPARABEN (UNII: 3QPI1U3FV8)	0.03 mg  in 1 mL
ETHYLPARABEN (UNII: 14255EXE39)	0.02 mg  in 1 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH)	0.03 mg  in 1 mL
PERFLUNAFENE (UNII: 54A06VV62N)	0.239952 mg  in 1 mL
CITRAL (UNII: T7EU0O9VPP)	0.001551 mg  in 1 mL
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)	0.00279 mg  in 1 mL
LINALOOL, (+)- (UNII: F4VNO44C09)	0.024963 mg  in 1 mL
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)	0.008448 mg  in 1 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH)	0.005 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.002 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70963-001-02	30 in 1 BOX	10/11/2016	12/31/2019
1	NDC: 70963-001-01	30 mL in 1 BOTTLE; 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	10/11/2016	12/31/2019

Labeler - LABORATORIO GENOVE S.A. (464955435)

Registrant - LABORATORIO GENOVE S.A. (464955435)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATORIO GENOVE S.A.		464955435	manufacture(70963-001)

Revised: 2/2020

Document Id: 9e75ed9e-d3d0-2e62-e053-2995a90a3e81

34390-5

Set id: 3e9ecbb5-64c7-4811-e054-00144ff88e88

Version: 2

Effective Time: 20200213

 

LABORATORIO GENOVE S.A.