WHITE RAIN ANTIBACTERIAL HAND LAVENDER BREEZE- benzalkonium chloride liquid
International Wholesale, 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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White Rain Antibacterial Hand Soap LAVENDER BREEZE

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

External for hand washing to decrease bacteria on the skin.

Warnings

for external use only.

When using this product

avoid contact with eyes. In case of eye contact, flush with water.

Stop and consult a doctor if:

irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Pump into DRY hands, Lather vigorously for at least 15 seconds. Rinse and dry thoroughly.

Inactive Ingredients

Inactive Matter: Water(Aqua), Lauramine Oxide, Coco-Glucoside, Glyceryl Oleate, Cetrimonium Chloride, PEG-150 Distearate, Myristamine Oxide, Glycerin, Fragrance(Parfum), Citric Acid, Sodium Chloride, Disodium EDTA, Benzophenone-4, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Red No. 33, FD&C Blue No. 1.

Package Labeling:

Label3

WHITE RAIN ANTIBACTERIAL HAND LAVENDER BREEZE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52862-622
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
MYRISTAMINE OXIDE (UNII: J086PM3RRT)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SULISOBENZONE (UNII: 1W6L629B4K)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:52862-622-00	1 in 1 CASE	02/01/2023
1		221 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/01/2023

Labeler - International Wholesale, Inc. (161872676)

Revised: 1/2023

Document Id: f2875727-d4f5-739d-e053-2a95a90acee6

Set id: 664f2826-5fca-465b-945f-fa9d3608aa79

Version: 1

Effective Time: 20230118

International Wholesale, Inc.