Label: ATO POLLEN- glycerin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70784-005-01, 70784-005-02 - Packager: NSB Co., Ltd.
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep out of reach of children
- Uses
- Directions
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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
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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
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INGREDIENTS AND APPEARANCE
ATO POLLEN
glycerin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70784-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 10 g in 50 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70784-005-02 1 in 1 PACKAGE 09/22/2016 1 NDC:70784-005-01 50 mL in 1 CONTAINER; 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 09/22/2016 Labeler - NSB Co., Ltd. (689846922) Registrant - NSB Co., Ltd. (689846922) Establishment Name Address ID/FEI Business Operations NSB Co., Ltd. 689846922 manufacture(70784-005)