HAND SANITIZER ALCOHOL FREE WITH COCONUT OIL SHEA BUTTER- benzalkonium chloride lotion
BBC GROUP LIMITED

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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Beautyfrizz Hand Sanitizer Lotion bzk Coconut

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

■ Hand sanitizing lotion to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only.

When using this product

■ keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.

Stop use and ask a doctor if

irritation and redness develops and persists.

Keep out of reach of children

If swallowed, contact a doctor or Poison Control Center right away.

Directions

■ Apply a dime-sized amount onto hands and rub together until absorbed. ■ Supervise children under 6 years of age when using this product

Inactive ingredients

Water, Mineral Oil, Cetearyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-25, PEG-100 Stearate, Urea, Dimethicone, Shea (Butyrospermum Parkii) Butter, Phenoxyethanol, Xanthan Gum, Coconut (Cocos Nucifera) Seed Oil, Chlorphenesin, Sodium Hyaluronate

Package Label

package label

HAND SANITIZER ALCOHOL FREE WITH COCONUT OIL SHEA BUTTER
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76383-030
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
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
COCONUT OIL (UNII: Q9L0O73W7L)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARETH-25 (UNII: 36ALR4705B)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
UREA (UNII: 8W8T17847W)
DIMETHICONE (UNII: 92RU3N3Y1O)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
MINERAL OIL (UNII: T5L8T28FGP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76383-030-03	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/28/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/28/2020

Labeler - BBC GROUP LIMITED (421270060)

Name	Address	ID/FEI	Business Operations
Establishment
BBC GROUP LIMITED		421270060	manufacture(76383-030)