Label: HAND SANITIZER- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 78755-003-01, 78755-003-02 - Packager: Industrias San-Ber, S.A. de C.V.
- 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 January 27, 2022
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
- 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
- Package label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78755-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 30 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78755-003-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2022 2 NDC:78755-003-02 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/24/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/24/2022 Labeler - Industrias San-Ber, S.A. de C.V. (811819762) Registrant - Industrias San-Ber, S.A. de C.V. (811819762) Establishment Name Address ID/FEI Business Operations Industrias San-Ber, S.A. de C.V. 811819762 manufacture(78755-003)