Label: GRAPE FRUIT HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77753-005-01, 77753-005-02, 77753-005-03, 77753-005-04, view more77753-005-05, 77753-005-06, 77753-005-07, 77753-005-08, 77753-005-09, 77753-005-10 - Packager: SHANDISHI Biological Technology Co., Ltd.
- 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 July 15, 2020
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- DRUG FACTS
- Active ingredient
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Package Labeling
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INGREDIENTS AND APPEARANCE
GRAPE FRUIT HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77753-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) VITIS VINIFERA FRUIT OIL (UNII: YQ5Q4Y2Z8U) GLYCERIN (UNII: PDC6A3C0OX) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77753-005-01 12 in 1 BOX 07/15/2020 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:77753-005-02 12 in 1 BOX 07/15/2020 2 53 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:77753-005-03 12 in 1 BOX 07/15/2020 3 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:77753-005-04 2 in 1 BOX 07/15/2020 4 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:77753-005-05 12 in 1 BAG 07/15/2020 5 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 6 NDC:77753-005-06 8 in 1 BOX 07/15/2020 6 350 mL in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:77753-005-07 8 in 1 BOX 07/15/2020 7 400 mL in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:77753-005-08 8 in 1 BOX 07/15/2020 8 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 9 NDC:77753-005-09 4 in 1 BOX 07/15/2020 9 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:77753-005-10 4 in 1 BOX 07/15/2020 10 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 07/15/2020 Labeler - SHANDISHI Biological Technology Co., Ltd. (411868994) Establishment Name Address ID/FEI Business Operations SHANDISHI Biological Technology Co., Ltd. 411868994 manufacture(77753-005)