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Name:Babor Baborganic Calm And Relax
Manufacturer:Babor Cosmetics America, Corp.
Category:Over-the-counter (OTC) Marketed Drugs

Calm and Relax insert

Babor Cosmetics America, Corp.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


Calm and Relax insert

calm and relax cream
An extremely well tolerated face cream for sensitive skin. The fast acting, effective Anti Irritation Complex calms and relaxes the skin. Irritations and redness subside, leaving the skin more resistant to external influences. Fragrance free and colorant free.
Directions for applying creams: Apply mornings and evenings to cleansed skin.

image of carton label

Carton panel description

baborganic – Green Glamour Cosmetics. Made with pure, natural organic ingredients in an environmentally sound way.
Extremely well tolerated cream for very sensitive skin: calms the skin and reduces redness and sensitivity. Pure glacier water from Mont Cervin moisturizes, while meadowfoam seed oil repairs the skin. Edelweiss extract protects and strengthens. Oxygen Energy regenerates the skin and lets it breathe. An anti irritation complex has a calming and relaxing effect.

Without: synthetic colorants and fragrances, animal derived raw materials, petroleum based ingredients, paraffins, PEGs, irradiated ingredients and genetically modified raw materials.
With: natural perfume, ingredients that are organically grown, obtained from a sustainable source and in compliance with Ecocert standards. Clinical tests have confirmed the highest degree of skin tolerance and effectiveness.  

Ingredients: water (aqua), glycerin, butylene glycol, macadamia ternifolia seed oil, meadowfoam delta lactone, squlane, dicaprylyl carbonate, dicaprylyl ether, glyceryl stearate, limnanthes alba (meadowfoam) seed oil, prunus amygdalus dulcis (sweet almond) oil, tocopheryl acetate, panthenol, phenoxyethanol, potassium cetyl phosphate, cetearyl alcohol, hydrogenated palm glycerides, carbomer, allantoin, xanthan gum, ethylhexylglycerin, bisabolol, alcohol, potassium sorbate, leontopodium alpinum flower leaf extract, lactose, sodium hydroxie, hydrolyzed cicer seed extract, biosaccharide gum 1, disodium EDTA, lactic acid, whey protein (lactis proteinum), caprylic capric triglyceride, sodium benzoate, pantolactone, citric acid, ascorbyl palmitate, zingiber officinale (ginger) root extract, ascorbic acid.

panthenol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44924-005
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Panthenol (Panthenol) Panthenol .04875 mL  in 50 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
# Item Code Package Description Multilevel Packaging
1 NDC:44924-005-02 1 JAR ( JAR) in 1 CARTON contains a JAR (44924-005-01)
1 NDC:44924-005-01 50 mL in 1 JAR This package is contained within the CARTON (44924-005-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/01/2008

Labeler - Babor Cosmetics America, Corp. (139251763)
Name Address ID/FEI Operations
Dr. Babor GMBH & Co. KG 315989384 manufacture

Revised: 02/2010 Babor Cosmetics America, Corp.

Reproduced with permission of U.S. National Library of Medicine

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