72863-001_Rael Clean Sanitizing Wipes

Rael Clean Sanitizing Wipes by

Drug Labeling and Warnings

Rael Clean Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Rael, Inc., FIRSTCHAM CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RAEL CLEAN SANITIZING WIPES- benzalkonium chloride cloth 
Rael, Inc.

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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72863-001_Rael Clean Sanitizing Wipes

ACTIVE INGREDIENT

Active Ingredients: Benzalkonium Chloride 0.1%

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Phenoxyethanol, Glycerin, Sodium benzoate, Polysorbate 20, Disodium EDTA, Tocopheryl acetate, Citric acid

PURPOSE

Purpose: antiseptic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
â–  If swallowed, get medical help or contact a Posion Control Center right away

Uses

Uses:

Hand sanitizer to help reduce bacteria on skin

WARNINGS

Warnings

For external use only

Stop use and ask a doctor if irrigation or rash develops and continues for more than 72 hours

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

Directions:

â–  Wet hands thoroughly with product and allow to dry without wiping

â–  Discard wipes in trash receptacle after use
â–  Do not flush

Other information

Other information:

â–  Store in a cool dry place

RAEL CLEAN SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72863-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	Â
PHENOXYETHANOL (UNII: HIE492ZZ3T)	Â
GLYCERIN (UNII: PDC6A3C0OX)	Â
SODIUM BENZOATE (UNII: OJ245FE5EU)	Â
POLYSORBATE 20 (UNII: 7T1F30V5YH)	Â
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	Â
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	Â
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72863-001-01	54 g in 1 PACKAGE; Type 0: Not a Combination Product	07/08/2020	01/18/2023
2	NDC: 72863-001-02	108 g in 1 PACKAGE; Type 0: Not a Combination Product	07/08/2020	01/18/2023
3	NDC: 72863-001-03	432 g in 1 PACKAGE; Type 0: Not a Combination Product	07/08/2020	01/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/08/2020	01/18/2023

Labeler - Rael, Inc. (087378348)

Registrant - Rael, Inc. (087378348)

Establishment
Name	Address	ID/FEI	Business Operations
FIRSTCHAM CO., LTD		694707327	manufacture(72863-001)

Revised: 1/2023

Document Id: f288d5fd-087a-5831-e053-2a95a90a8c59

34390-5

Set id: 6242d41e-0cf3-4559-9048-2ddfa19e8470

Version: 4

Effective Time: 20230118

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