Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70897-012-01, 70897-012-02, 70897-012-03, 70897-012-04, view more70897-012-05, 70897-012-06, 70897-012-07, 70897-012-08, 70897-012-09, 70897-012-10, 70897-012-11, 70897-012-12 - Packager: Davemed Healthcare 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 30, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- USES
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WARNING:
Flammable.
Keep away from fire or flame.
For external use of onlyh.
WHEN USING THIS PRODUCT:
avoid contact with eyes in case of eye contact immediately flush eyes with water, call a doctor avoid contact with broken skin.
- DIRECTIONS:
- INGREDIENTS:
- PURPOSE
- OTHER SAFETY INFORMATION
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70897-012 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 CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) WATER (UNII: 059QF0KO0R) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) TROLAMINE (UNII: 9O3K93S3TK) PEG-40 SORBITAN DIISOSTEARATE (UNII: JL4CCU7I1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70897-012-01 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 2 NDC:70897-012-02 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 3 NDC:70897-012-03 80 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 4 NDC:70897-012-04 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 5 NDC:70897-012-05 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 6 NDC:70897-012-06 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 7 NDC:70897-012-07 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 8 NDC:70897-012-08 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 9 NDC:70897-012-09 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 10 NDC:70897-012-10 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 11 NDC:70897-012-11 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 12 NDC:70897-012-12 3780 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/30/2020 Labeler - Davemed Healthcare Co., Ltd (529128716) Establishment Name Address ID/FEI Business Operations Davemed Healthcare Co., Ltd 529128716 manufacture(70897-012)
