Label: 75% ALCOHOL HAND SANITIZER gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79316-007-01, 79316-007-02, 79316-007-03, 79316-007-04, view more79316-007-05, 79316-007-06, 79316-007-07, 79316-007-08, 79316-007-09, 79316-007-10 - Packager: PHOENYX DISTRIBUTING, LLC
- 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 June 26, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
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Warnings
For external use only
Flammable, Keep away from fire or flame
Do not use near eyesIn case of eye contact flush with water for 15 minutes
If imitation persists stop use of product and get medical attention
Keep out of reach of childrenIn case of accidental ingestion seek medical attention orcontact a poison contro center immediately
- 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
75% ALCOHOL HAND SANITIZER
75% alcohol hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79316-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength AMINOMETHYLPROPANOL (UNII: LU49E6626Q) WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79316-007-08 750 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 2 NDC:79316-007-06 480 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 3 NDC:79316-007-07 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 4 NDC:79316-007-05 300 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 5 NDC:79316-007-04 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 6 NDC:79316-007-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 7 NDC:79316-007-09 950 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 8 NDC:79316-007-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 9 NDC:79316-007-03 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 10 NDC:79316-007-10 2000 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/30/2020 Labeler - PHOENYX DISTRIBUTING, LLC (128029831) Establishment Name Address ID/FEI Business Operations PHOENYX DISTRIBUTING, LLC 128029831 label(79316-007) Establishment Name Address ID/FEI Business Operations Fortress Expert Co., Ltd 543358697 manufacture(79316-007)