Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79886-002-01, 79886-002-02, 79886-002-05, 79886-002-10, view more79886-002-50 - Packager: AKKIM YAPI KIMYASALLARI SANAYI VE TICARET ANONIM SIRKETI
- 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 December 30, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel 100 ml
- Package Label, Principal Display Panel 250 ml
- Package Label, Principal Display Panel 500
- Package Label, Principal Display Panel 1000 ml
- Package Label, Principal Display Panel 5000 ml
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79886-002 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 940 (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79886-002-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2020 2 NDC:79886-002-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2020 3 NDC:79886-002-05 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2020 4 NDC:79886-002-10 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2020 5 NDC:79886-002-50 5000 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 08/20/2020 Labeler - AKKIM YAPI KIMYASALLARI SANAYI VE TICARET ANONIM SIRKETI (366467348) Establishment Name Address ID/FEI Business Operations AKKIM YAPI KIMYASALLARI SANAYI VE TICARET ANONIM SIRKETI 366467348 manufacture(79886-002) , pack(79886-002) , label(79886-002)