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NDC 63645-0174-02 Sanell Hand Sanitizer 6.3 mL/10mL Details

Sanell Hand Sanitizer 6.3 mL/10mL

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

Product Information

NDC	63645-0174
Product ID	63645-174_e5314981-da30-4353-a4ad-3b1c5a96054e
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	SPRAY
Route	TOPICAL
Active Ingredient Strength	6.3
Active Ingredient Units	mL/10mL
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 63645-0174-02 (63645017402)

Pricing Information	N/A
NDC Package Code	63645-174-02
Billing NDC	63645017402
Package	10 mL in 1 BOTTLE (63645-174-02)
Marketing Start Date	2019-08-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 0a6cc2a8-f568-45ae-8d82-a70103c774c7 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. Do not use in the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor: if irritation and redness develop and persists for more than 72 hours.

Directions

Wet hands thoroughly with product and allow to dry without wiping. Supervise children in the use of this product.

Inactive Ingredients

Dimethicone, Disodium EDTA, DMDM Hydantoin, Fragrance, Polysorbate 20, Propanediol, Water.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SANELL HAND SANITIZER

alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63645-174
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	6.3 mL in 10.0 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)	0.004 mL in 10.0 mL
WATER (UNII: 059QF0KO0R)	3.581 mL in 10.0 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63645-174-02	10.0 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/12/2019

Labeler - OraLabs (801824756)

Registrant - OraLabs (801824756)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(63645-174) , LABEL(63645-174)

Revised: 1/2022

Document Id: e5314981-da30-4353-a4ad-3b1c5a96054e

Set id: 0a6cc2a8-f568-45ae-8d82-a70103c774c7

Version: 2

Effective Time: 20220121