Label: MANOLIA DISINFECTANT WET WIPE- benzalkonium chloride cloth
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Contains inactivated NDC Code(s)
NDC Code(s): 80887-006-06 - Packager: TELLINI INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 16, 2020
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- Official Label (Printer Friendly)
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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:
- Benzalkonium Chloride (0.45%, volume/volume (w/v)) in an aqueous solution.
- Glycerol (0.8% w/v).
- Phenoxyethanol (0.1% w/v).
- Cocamidopropyl Betaine (0.4% w/v).
- Polysorbate 20 (0.2% w/v).
- Peg-7 Glyceryl Cocoate (0.3% w/v).
- Citric Acid (0.1% w/v).
- 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)
- Purpose
- Use
- Warnings
- Do not use
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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
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
MANOLIA DISINFECTANT WET WIPE
benzalkonium chloride clothProduct 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 ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) 0.02 g in 100 g JASMINE LACTONE (UNII: H8558L43SR) 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 CHLORPHENESIN (UNII: I670DAL4SZ) 0.05 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 Product Characteristics Color Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80887-006-06 100 g in 1 CANISTER; Type 0: Not a Combination Product 10/25/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2020 Labeler - TELLINI INC. (117014846) Registrant - TELLINI INC. (117014846) Establishment Name Address ID/FEI Business Operations DOBOLV (QUANZHOU) PAPER CO LTD 550022046 manufacture(80887-006)
