Sanitizing Wipes by All Clean Natural Ltd.

Sanitizing Wipes by

Drug Labeling and Warnings

Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by All Clean Natural Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Wipes90 Wipes

SANITIZING WIPES 
0.13% benzakonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78806-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78806-300-3090 in 1 CANISTER12/01/2020
15 mL in 1 PACKAGE; Type 0: Not a Combination Product
2NDC: 78806-300-40110 in 1 CANISTER12/01/2020
25 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/01/202012/01/2020
Labeler - All Clean Natural Ltd. (203593355)
Establishment
NameAddressID/FEIBusiness Operations
All Clean Natural Ltd.203593355manufacture(78806-300)

Revised: 7/2023
 

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