Hand Sanitizer by Pommes Frites Candle Co.

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Pommes Frites Candle Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- isopropyl alcohol liquid 
Pommes Frites Candle Co.

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.

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This is a hand sanitizer manufactured using guidelines from the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

Active Ingredient(s)

Isopropyl Alcohol 72% Purpose: Antimicrobial

Purpose

Antimicrobial

Use

For hand sanitizing to decrease bacteria on the skin. For use when soap and water are not available.

Warnings

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

When using this product

• Avoid contact with eyes. In case for eye contact, flush eyes with water.
• Do not inhale or ingest.

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

• Spray product thoroughly to cover hands. Rub hands together briskly until dry.
• For children under 6, use only under adult supervision.

Other information

• Do not store above 100 F.
• May discolor some fabrics and surfaces.

Inactive ingredients

Water, Glycerin, Propylene Glycol, Fine Fragrance Oil (Contains: Benzyl Benzoate)

Package Label - Principal Display Panel

2 FL OZ // 60 ML NDC: 80000-0004-1

HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80000-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80000-0004-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/16/2020	12/30/2020

Labeler - Pommes Frites Candle Co. (059674936)

Establishment
Name	Address	ID/FEI	Business Operations
Pommes Frites Candle Co.		059674936	manufacture(80000-0004)

Revised: 5/2021

Document Id: c1fec3ff-e132-600e-e053-2a95a90a48ff

34390-5

Set id: ae6fbb0c-4411-845e-e053-2995a90a1d47

Version: 2

Effective Time: 20210510