Label: ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER- ethanol alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 81209-200-01, 81209-200-02, 81209-200-03 - Packager: BLUETRACK INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 21, 2021
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- Active Ingredient(s)
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INGREDIENTS AND APPEARANCE
ADVANCED GEL HAND SANITIZER SOOTHING LAVENDER
ethanol alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81209-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL in 100 mL Inactive Ingredients Ingredient Name Strength D&C RED NO. 30 (UNII: 2S42T2808B) ALOE VERA LEAF (UNII: ZY81Z83H0X) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) TOCOPHEROL (UNII: R0ZB2556P8) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER 940 (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) FRAGRANCE LAVENDER ORC1800979 (UNII: 1B40MIN2W5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81209-200-01 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/01/2020 2 NDC:81209-200-02 1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/01/2020 3 NDC:81209-200-03 60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/01/2020 Labeler - BLUETRACK INC (135029937) Registrant - NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD (544493972) Establishment Name Address ID/FEI Business Operations NINGBO OCEANSTAR CHEMICAL PRODUCTS CO.LTD 544493972 manufacture(81209-200)