HAND SANITIZER- alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Creative Essences
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic, Hand Sanitizer Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated use. - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Authorization status:
OTC monograph not final
Authorization number:
70658-124-31

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HAND SANITIZER- alcohol gel

Creative Essences

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.

----------

Fresh Nectar Hand Sanitizer 2 fl oz

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpos e

Antiseptic, Hand Sanitizer

Us e

Hand Sanitizer to help reduce bacteria that potentially can cause disease. Recommended for repeated

use.

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 wounds

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.

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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Aloe vera extract, aminomethylpropanol, carbomer, cyclomethicone 5, fragrance, 3-o-ethyl ascrobic

acid, vitamin e acetate, water

Package Label - Principal Display Panel

60 mL NDC: 70658-124-31

HAND SANITIZER

alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 58 -124

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

8 0 mL in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

3 -O -ETHYL ASCO RBIC ACID (UNII: 6 MW6 0 CB71P)

0 .0 2 g in 10 0 mL

AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)

0 .0 2 g in 10 0 mL

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

0 .0 0 3 g in 10 0 mL

CYCLO METHICO NE 5 (UNII: 0 THT5PCI0 R)

2.31 g in 10 0 mL

CARBO MER HO MO PO LYMER, UNSPECIFIED TYPE (UNII: 0 A5MM30 7FC)

0 .59 mL in 10 0 mL

WATER (UNII: 0 59 QF0 KO0 R)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

0 .0 2 g in 10 0 mL

Creative Essences

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 58 -124-31

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

11/20 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 3/30 /20 20

Labeler -

Creative Essences (079120182)

Registrant -

Creative Essences (079120182)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Creative Essences Inc

0 79 120 18 2

manufacture(70 6 58 -124) , pack(70 6 58 -124) , label(70 6 58 -124)

Revised: 11/2020

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