SANITIZING WIPES- 0.13% benzakonium chloride cloth
All Clean Natural 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.

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OTC Active Ingredient Section

Active Ingredient: Benzalkonium Chloride 0.13% w/w

OTC Purpose Section

Purpose: Antimicrobial Agent

Recommended Use

- Antiseptic skin cleanser

recommended use

antiseptic cleanser

Recommended Route of administration

Topical

Duration of use and recommended dose

children 2 -11 years Adolescents 12 -17 years Adults 18 years and older

Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Keep Out Of Reach Of Children Section

Keep out of reach of children. If swallowed, call a poison control center or get medical help right away. Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Contraindications: Do not use on children/infants less than 2 years of age (unless directed by a doctor/ physician/ health care practitioner/ health care provider/ health care professional).

Warnings Section

- For external use only. -When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. -Stop use and ask a doctor if irritation and redness develops. -Keep out of reach of children. If swallowed, call a posion control centre or get medical help right away.

Inactive Ingredient Section

Inactive Ingredients: Aloe barbadensis leaf juice, cocamidopropyl pg-dimonium chloride phosphate, panthenol, purified water, soyethyl morpholinium ethosulfate, vaccinium angustifolium (blueberry) fruit extract, fragrance

Storage

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Questions?

Call 1-866-455-9959

Primary Display Label

110 Wipes 90 Wipes

SANITIZING WIPES
0.13% benzakonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78806-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PANTHENOL (UNII: WV9CM0O67Z)
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)
COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78806-300-30	90 in 1 CANISTER	12/01/2020
1		5 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:78806-300-40	110 in 1 CANISTER	12/01/2020
2		5 mL in 1 PACKAGE; 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	part333A	12/01/2020	12/01/2020

Labeler - All Clean Natural Ltd. (203593355)

Name	Address	ID/FEI	Business Operations
Establishment
All Clean Natural Ltd.		203593355	manufacture(78806-300)

Revised: 7/2023

Document Id: 00f2b662-d5a7-5424-e063-6294a90a98c4

Set id: b42c2735-eacf-4db9-e053-2a95a90a229f

Version: 3

Effective Time: 20230720

All Clean Natural Ltd.