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NDC 63645-0166-01 Sanell Hand Sanitizer 58.1 mg/g Details

Sanell Hand Sanitizer 58.1 mg/g

Sanell Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by OraLabs. The primary component is ALCOHOL.

Product Information

NDC	63645-0166
Product ID	63645-166_1123e0c4-ab0b-4079-aa5e-06d01e6d7cf4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sanell Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	58.1
Active Ingredient Units	mg/g
Substance Name	ALCOHOL
Labeler Name	OraLabs
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63645-0166-01 (63645016601)

Pricing Information	N/A
NDC Package Code	63645-166-01
Billing NDC	63645016601
Package	1 g in 1 CONTAINER (63645-166-01)
Marketing Start Date	2018-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e3b85008-4455-46d1-ad33-fb0c69aeb60c Details

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

INGREDIENTS AND APPEARANCE

SANELL HAND SANITIZER

alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-166
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	58.10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.010 mg in 1 g
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)	.310 mg in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	.500 mg in 1 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-166-01	1 g in 1 CONTAINER; Type 0: Not a Combination Product	03/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/07/2018

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-166) , LABEL(63645-166)

Revised: 11/2022

Document Id: 1123e0c4-ab0b-4079-aa5e-06d01e6d7cf4

Set id: e3b85008-4455-46d1-ad33-fb0c69aeb60c

Version: 2

Effective Time: 20221111