Label: SANITELLE ADVANCED HAND SANITIZER WITH MACADAMIA OIL- alcohol gel
- NDC Code(s): 80068-004-50
- Packager: BENTUS LABORATORII, OOO
- 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.
Updated February 25, 2021
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- Active Ingredient(s)
- Do not use
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
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
SANITELLE ADVANCED HAND SANITIZER WITH MACADAMIA OIL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80068-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength MACADAMIA OIL (UNII: 515610SU8C) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80068-004-50 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/19/2021 Labeler - BENTUS LABORATORII, OOO (354757383) Establishment Name Address ID/FEI Business Operations BENTUS LABORATORII, OOO 354757383 manufacture(80068-004)