Label: ATO POLLEN- glycerin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 7, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Glycerin (20%)

  • Purpose

    Skin Protectant

  • Keep out of reach of children

    Do not swallow. In case of accidental ingestion, seek professional assistance

  • Uses

    Moisturizes skin. Keep skin soft and smooth

  • Directions

    After cleansing face or bath, dry completely and apply the adequate amount on face, and body. Spread out thoroughly until it is absorbed. Apply it frequently as needed.

  • Inactive Ingredients

    WATER, POLLEN EXTRACT, DIPROPYLENE GLYCOL, ISOPENTYLDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOPROPYL ISOSTEARATE, PENTAERYTHRITYL TETRAISOSTEARATE, CETEARYL ALCOHOL, CETEARYL OLIVATE, 1,2-HEXANEDIOL, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, SORBITAN OLIVATE, GLYCERYL STEARATE, DIMETHICONE, PHENOXYETHANOL, POLYACRYLAMIDE, PEG-100 STEARATE, C13-14 ISOPARAFFIN, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ETHYLHEXYLGLYCERIN, LAURETH-7, DISODIUM EDTA

  • Warnings

    For external use only
    Do not use when Your skin is red, inflamed, irritated or painful
    When using this product
     Do not apply on other parts of the body
     Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
     Do not apply directly to wound or open cut.
    Stop use and ask doctor if rash or irritation on skin develops and lasts. 

    Store at room temperature

  • Ato Pollen Cream

    atocream

  • INGREDIENTS AND APPEARANCE
    ATO POLLEN 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70784-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BEE POLLEN (UNII: 3729L8MA2C)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISOPENTYLDIOL (UNII: 19NOL5474Q)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAURETH-7 (UNII: Z95S6G8201)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70784-005-021 in 1 PACKAGE09/22/2016
    1NDC:70784-005-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/22/2016
    Labeler - NSB Co., Ltd. (689846922)
    Registrant - NSB Co., Ltd. (689846922)
    Establishment
    NameAddressID/FEIBusiness Operations
    NSB Co., Ltd.689846922manufacture(70784-005)