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NDC 63645-0175-03 Sanell Hand Sanitizer 9.45 mL/15mL Details

Sanell Hand Sanitizer 9.45 mL/15mL

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	63645-0175
Product ID	63645-175_6ab29d66-c009-445c-9a9b-2cc2301209a2
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	9.45
Active Ingredient Units	mL/15mL
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	2023-12-31

Package

Package Images

NDC 63645-0175-03 (63645017503)

Pricing Information	N/A
NDC Package Code	63645-175-03
Billing NDC	63645017503
Package	15 mL in 1 BOTTLE (63645-175-03)
Marketing Start Date	2018-03-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a868e834-9b07-4bf3-aeae-9a9abe617136 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:63645-175
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	9.45 mL in 15 mL

Ingredient Name	Strength
Inactive Ingredients
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.0015 mL in 15 mL
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)	0.048 mL in 15 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.006 mL in 15 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-175-03	15 mL in 1 BOTTLE; 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(63645-175) , LABEL(63645-175)

Revised: 1/2022

Document Id: 6ab29d66-c009-445c-9a9b-2cc2301209a2

Set id: a868e834-9b07-4bf3-aeae-9a9abe617136

Version: 2

Effective Time: 20220121