Label: HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 73549-008-01, 73549-008-02, 73549-008-03, 73549-008-04 - Packager: Fortress Expert Co., Ltd
- Category: HUMAN OTC DRUG LABEL
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 23, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from open flame and sources of heat
External use only
Avoid contact with eyes , in the case of eyes contact, rinse eyes thoroughly with water.
Stop use and consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops
Keep out of reach of children
- DO NOT USE
- WHEN USING
- STOP USE
- Keep out of reach of children
- Directions
- Other information
- Inactive ingredients
- Package Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73549-008 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. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 4 (UNII: X3W0AM1JLX) POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73549-008-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2020 2 NDC:73549-008-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2020 3 NDC:73549-008-03 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2020 4 NDC:73549-008-04 1800 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/23/2020 Labeler - Fortress Expert Co., Ltd (543358697) Registrant - Fortress Expert Co., Ltd (543358697) Establishment Name Address ID/FEI Business Operations Fortress Expert Co., Ltd 543358697 manufacture(73549-008)