Sanell Hand Sanitizer by OraLabs Drug Facts

Sanell Hand Sanitizer by

Drug Labeling and Warnings

Sanell Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANELL HAND SANITIZER- alcohol gel 
OraLabs

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.

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Drug Facts

Active ingredient

Ethyl Alcohol 63.00%

Purpose

Antiseptic

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only: Hands. Flammable. Keep away from fire or flame. When using this product: keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor: if irritation and redness develop. Condition persists for more than 72 hours.

Directions

Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

Inactive Ingredients

Carbomer, DMDM Hydantoin, Fragrance, Isopropanol, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water.

Package/Label Principal Display Panel

Sixty-four Fluid Ounce
SANELL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 63645-171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL1190.7 mL  in 1890 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.189 mL  in 1890 mL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) 6.048 mL  in 1890 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 8.316 mL  in 1890 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 63645-171-101890 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/202012/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/202012/21/2021
Labeler - OraLabs (801824756)
Registrant - OraLabs (801824756)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(63645-171) , LABEL(63645-171)

Revised: 12/2021

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