Label: REFRESH NATURE CREAM- citric acid, glycerin cream

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated June 22, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • purpose

    Acne Control

  • Use

    ​Daily Moisturizing and skin repairing

  • Warnings

    Do not use on cuts, or if you have extremely sensitive skin

    Do not mix the product with other AHA, BHA, Steroids related Products

    which can cause irritation characterized by redness,

    itching, and burning

  • Warnings

    When using this product do not use in or near the eyes.

  • Warnings

    Stop use if irritation become severe and ask a doctor

  • Warnings

    For external use only avoid contact with the eyes,lips and mouth

  • Warnings

    Keep out of reach of children If swallowed, please get medical help

  • Directions

    Directions Cleanse the skin thoroughly before applying

    the product * Apply gently a thin layer on the desired area 2 to 3 times daily

  • active ingredient

    Glycerin 5.0 % Skin Protection

    Xanthium Strumarium Fruit Extract 0.17% Antioxidant

    Cnidium Monnieri Fruit Extract 0.17% Anti Flammatory

    Angelica Acutiloba Root Extract 0.17% Skin lightening

    Citric Acid 0.01% Exfoliating

    Malic Acid 0.003% Exfoliating

  • Inactive Ingredients

    Water, Butylene Glycol Hydrogenated Polydecene, Beeswax, Cetearyl Olivate, Methylpropanediol, Pentaerythrityl Tetraethylhexanoate, Ethylhexyl Palmitate, Cetyl Ethylhexanoate, Sorbitan Olivate, Stearic Acid, Rhus Semialata Gall Extract, Hexanediol, Hydrolyzed Collagen, Cetearyl Alcohol , Dimethicone, Sodium Acrylate, Sodium Acryloyldimethyl, Taurate, Copolymer,Palmitic Acid, Propanediol, Isohexadecane, Hydroxyacetophenone, Carbomer, Arginine, Limonia Acidissima Extract,Centella Asiatica Extract, Chlorphenesin, Ethylhexylglycerin, Polysorbate 80, Xanthan Gum,Fragrance,Benzyl Salicylate,Coumarin, Butylphenyl Methylpropional, Limonene, Linalool, Disodium EDTA,Sodium Lactate,Arachidic Acid,Citric Acid,Sodium PCA,Myristic Acid,Lactic Acid,Pyruvic Acid,Tartaric Acid,Alcohol,Polysorbate 20, Madecassoside

  • Daily Hydrating Cream for Acne Control

    Daily Hydrating Cream for Acne Control

    1

  • INGREDIENTS AND APPEARANCE
    REFRESH NATURE CREAM 
    citric acid, glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82790-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    XANTHIUM STRUMARIUM FRUIT (UNII: TN770YC17C) (XANTHIUM STRUMARIUM FRUIT - UNII:TN770YC17C) XANTHIUM STRUMARIUM FRUIT0.17 g  in 100 g
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS) (CNIDIUM MONNIERI FRUIT - UNII:V1IA3S3CUS) CNIDIUM MONNIERI FRUIT0.17 g  in 100 g
    MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP) MALIC ACID0.003 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 g
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30) (ANGELICA ACUTILOBA ROOT - UNII:3W51R3EK30) ANGELICA ACUTILOBA ROOT0.17 g  in 100 g
    LIMONIA ACIDISSIMA WHOLE (UNII: MU5C4X2819) (LIMONIA ACIDISSIMA WHOLE - UNII:MU5C4X2819) LIMONIA ACIDISSIMA WHOLE0.17 g  in 100 g
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.01 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)  
    TAURINE (UNII: 1EQV5MLY3D)  
    GLATIRAMER ACETATE (UNII: 5M691HL4BO)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    ARACHIDIC ACID (UNII: PQB8MJD4RB)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    RHUS CHINENSIS GALL (UNII: 4W3Y2V7J3R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARGININE (UNII: 94ZLA3W45F)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HEXANEDIOL (UNII: ZIA319275I)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    PYRUVIC ACID (UNII: 8558G7RUTR)  
    TARTARIC ACID (UNII: W4888I119H)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82790-301-01110 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/22/2022
    Labeler - GP International Corp. (695896955)
    Registrant - GP International Corp. (695896955)
    Establishment
    NameAddressID/FEIBusiness Operations
    GP International Corp.695896955manufacture(82790-301)