Label: INSTANT HAND SANITIZER GEL- alcohol gel
- NDC Code(s): 53598-007-01
- Packager: Bonita Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Drug Facts
Ethyl Alcohol 62%Close
- To help decrease bacteria on the skin.
- Recommended for repeated use.
For external use only. Flammable, keep away from fire or flame.
- Keep out of eyes. In case of eye contact, flush it thoroughly with water, seek medical attention immediately.
- Avoid contact with broken skin.
- Keep away from children. If swallowed, seek medical attention immediately. Children must only use this product under adult supervision.
- Place small amount of Bonita sanitizer in your palm. Thoroughly spread on both hands and rub together until dry.
- Other Information
- Store below 105 ˚F.
- May discolor some fabrics.
- Inactive Ingredients
- Propylene glycol
- Isopropyl alcohol
- Carbomer 940
- INGREDIENTS AND APPEARANCE
INSTANT HAND SANITIZER GEL
ethyl alcohol gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53598-007 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 18.6 mL in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) CARBOMER 940 (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53598-007-01 30 mL in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 09/12/2013 Labeler - Bonita Pharmaceuticals LLC (004219442) Establishment Name Address ID/FEI Business Operations Bonita Pharmaceuticals LLC 004219442 label(53598-007)