MANOLIA DISINFECTANT WET WIPE- benzalkonium chloride cloth 
TELLINI 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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MANOLIA DISINFECTANT WET WIPE

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Benzalkonium Chloride (0.45%, volume/volume (w/v)) in an aqueous solution.
  2. Glycerol (0.8% w/v).
  3. Phenoxyethanol (0.1% w/v).
  4. Cocamidopropyl Betaine (0.4% w/v).
  5. Polysorbate 20 (0.2% w/v).
  6. Peg-7 Glyceryl Cocoate (0.3% w/v).
  7. Citric Acid (0.1% w/v).
  8. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Benzalkonium Chloride 0.45% w/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

For external use only.

Do not use

When using this product keep out of eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Citric acid, Cocoamidopropyl betaine, glycerin, Phenoxyethanol, Polysorbate 20, Peg-7 glyceryl cocoate, purified water USP

Package Label - Principal Display Panel

72 pcs NDC: 86812-002-01 72 pcs

MANOLIA DISINFECTANT WET WIPE 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80887-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.02 g  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8) 0.1 g  in 100 g
GLYCEROL FORMAL (UNII: 3L7GR2604E) 0.5 g  in 100 g
WATER (UNII: 059QF0KO0R) 98.81 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.2 g  in 100 g
BETAINE (UNII: 3SCV180C9W) 0.1 g  in 100 g
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.05 g  in 100 g
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.05 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.02 g  in 100 g
CHLORPHENESIN (UNII: I670DAL4SZ) 0.05 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80887-006-05100 g in 1 CANISTER; Type 0: Not a Combination Product10/25/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - TELLINI INC. (117014846)
Registrant - TELLINI INC. (117014846)
Establishment
NameAddressID/FEIBusiness Operations
DOBOLV (QUANZHOU) PAPER CO LTD550022046manufacture(80887-006)

Revised: 11/2020
Document Id: b402a253-019b-d2d4-e053-2a95a90a9dd0
Set id: b258a597-6fe3-154c-e053-2a95a90a48cc
Version: 2
Effective Time: 20201113
 
TELLINI INC.