MANOLIA DISINFECTANT WET WIPE- benzalkonium chloride cloth

Manolia Disinfectant Wet Wipe by

Drug Labeling and Warnings

Manolia Disinfectant Wet Wipe by is a Otc medication manufactured, distributed, or labeled by TELLINI INC., DOBOLV (QUANZHOU) PAPER CO LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

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

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

Directions

• Open package, remove one wet wipes to clean your hands and body. Reseal, keep closed to prevent evaporation.
• Allow to dry without wiping. Discard properly after use.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store at room temperature.
• Do not flush down toilet.

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

INGREDIENTS AND APPEARANCE

MANOLIA DISINFECTANT WET WIPE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80887-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)	0.05 g  in 100 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)	0.05 g  in 100 g
GLYCEROL FORMAL (UNII: 3L7GR2604E)	0.5 g  in 100 g
WATER (UNII: 059QF0KO0R)	98.81 g  in 100 g
FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)	0.1 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T)	0.2 g  in 100 g
BETAINE (UNII: 3SCV180C9W)	0.1 g  in 100 g
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)	0.05 g  in 100 g
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)	0.02 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.02 g  in 100 g

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80887-006-04	100 g in 1 CANISTER; Type 0: Not a Combination Product	10/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - TELLINI INC. (117014846)

Registrant - TELLINI INC. (117014846)

Establishment
Name	Address	ID/FEI	Business Operations
DOBOLV (QUANZHOU) PAPER CO LTD		550022046	manufacture(80887-006)