Pipa Mint by CELOR L.L.P.

Pipa Mint by

Drug Labeling and Warnings

Pipa Mint by is a Otc medication manufactured, distributed, or labeled by CELOR L.L.P.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PIPA MINT- benzalkonium chloride cloth 
CELOR L.L.P.

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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Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use

• In the eyes.
• If you are allergic to any of the ingredients.

When using this product if eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or redness develops and persist for more than 72 hours.

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

Directions

• Storage: Store at room temperature
• Dispensing: Peel back from label. Remove wipe(s). Release by pressing label over opening.
• Use: Apply wipe thoroughly to hands as desired. Allow to dry without wiping.
• Disposal: Dispose of used wipes in trash receptacle after use. Do not flush.

Inactive ingredients

Water, Glycerin, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Polysorbate 20, Polyaminopropyl Biguanide, 2-Bromo-2-nitropropane-1,3-diol, Tocopheryl Acetate, Citric Acid.

Package Label - Principal Display Panel

PIPA MINT 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90062-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90062-001-01	10 in 1 BOX	08/01/2020	08/01/2020
1		20 in 1 POUCH
1		4 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 90062-001-02	5 in 1 BOX	08/01/2020	08/01/2020
2		20 in 1 POUCH
2		4 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 90062-001-03	10 in 1 BOX	08/01/2020	08/01/2020
3		20 in 1 POUCH
3		4 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 90062-001-04	5 in 1 BOX	08/01/2020	08/01/2020
4		20 in 1 POUCH
4		4 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020	08/01/2020

Labeler - CELOR L.L.P. (117601632)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(90062-001)

Revised: 10/2021

Document Id: ceb428e0-d6f7-57b7-e053-2995a90afcda

34390-5

Set id: f2053e15-10fd-404b-a83c-411fa253d293

Version: 3

Effective Time: 20211019

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