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NDC 81151-0102-01 Rise Hand Sanitizer 63 mL/100mL Details

Rise Hand Sanitizer 63 mL/100mL

Rise Hand Sanitizer is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Shop Safely, LLC.. The primary component is ALCOHOL.

Product Information

NDC	81151-0102
Product ID	81151-102_41eeeb9d-1e56-4df4-9130-298271847c48
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	Rise Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	63
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Shop Safely, LLC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	n/a

Package

Package Images

NDC 81151-0102-01 (81151010201)

Pricing Information	N/A
NDC Package Code	81151-102-01
Billing NDC	81151010201
Package	437 mL in 1 BOTTLE (81151-102-01)
Marketing Start Date	2021-03-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL bda5017f-3c56-4f33-a98d-f1e38e4af9d3 Details

Active ingredient[s]:

Ethyl Alcohol 63% v/v

Purpose

Antiseptic

Use[s]

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

•: in children less than 2 months of age
•: on open skin wound or on broken skin

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 at 1-800-222-1222

Directions

•: Pump enough product on palms to cover hands. Rub hands together until dry.
•: Children under 6 years of age should be supervised when using this product.

Other Information

•: Store between 15-30C (59-86F)
•: Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

aminomethyl propanol, carbomer, fragrance, glycerin, water.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Safely™

Hand Sanitizer

Rise

16 fl oz (1 pt) 473 mL

Made in the USA with US and imported

components This bottle is made with 10% PCR

Label

INGREDIENTS AND APPEARANCE

RISE HAND SANITIZER

ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81151-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	63 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81151-102-01	437 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/01/2021	06/30/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	03/01/2021	06/30/2024

Labeler - Shop Safely, LLC. (117715242)

Revised: 3/2022

Document Id: 41eeeb9d-1e56-4df4-9130-298271847c48

Set id: bda5017f-3c56-4f33-a98d-f1e38e4af9d3

Version: 2

Effective Time: 20220309