OLLIE HAND SANITIZER- alcohol liquid
F.P. Aromatics Singapore Pte Ltd

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.

----------

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

To sanitize hand when soap and water are not available.

Warnings

For external use only. Keep away from fire or flame.

Do not use

on open wounds

on children less than 4 months of age.

When using this product, keep out of eyes, ears, mouth.
Stop use and ask a doctor if irritation or rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Direction

Spray on hands and rub them together gently
Supervise children under 6 years of age in the use of this product

Other information

Store between 15° - 30°C (59° - 86°F)

Inactive ingredient

Aloe vera, Orange oil, Peppermint oil, Tea tree oil, Water

Product label

image description

OLLIE HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81634-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ORANGE OIL (UNII: AKN3KSD11B)
PEPPERMINT OIL (UNII: AV092KU4JH)
TEA TREE OIL (UNII: VIF565UC2G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81634-001-01	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/01/2021

Labeler - F.P. Aromatics Singapore Pte Ltd (595391354)

Name	Address	ID/FEI	Business Operations
Establishment
F.P. Aromatics Singapore Pte Ltd		595391354	manufacture(81634-001)

Revised: 5/2021

Document Id: c24a04d2-b087-69dd-e053-2995a90aa329

Set id: cfb33479-2d53-4925-9fdc-acf2e6e514ab

Version: 1

Effective Time: 20210514

F.P. Aromatics Singapore Pte Ltd