Antibacterial wipes by Relax Time, Inc. sanitizer

Antibacterial wipes by

Drug Labeling and Warnings

Antibacterial wipes by is a Otc medication manufactured, distributed, or labeled by Relax Time, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WIPES- benzalkonium chloride liquid 
Relax Time, 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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sanitizer

ACTIVE INGREDIENT

Benzalkonium Chloride 0.2%

PURPOSE

Antimicrobial

USE

Reduces bacteria on skin.

WARNINGS

For external use only.

when using this product

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

stop use and ask a doctor if irritationor or rash edvelopes and continues for more than 72 hours.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

Do not use if you are allergic to any of the ingredients.

INACTIVE INGREDIEINT

Water, Orange oil, Pinus densiflora extract

OTHER INFORMATION

Keep tightly closed. Store away from direct sunlight or high temperature. May discolor some fabrics. Use away from electric devices.

QUESTIONS OR COMMENTS?

mpluscareus@gmail.com, M-F

DIRECTIONS

Adults and Children 2 years and over. Wet hands thoroughly with product and allow to dry without wiping. Children under 2 years consult a doctor before use.

LABEL

79777-301-01

ANTIBACTERIAL WIPES 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79777-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	99.4 mL  in 100 g
ORANGE OIL (UNII: AKN3KSD11B)	0.1 mL  in 100 g
PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)	0.4 mL  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79777-301-01	56 g in 1 POUCH; Type 0: Not a Combination Product	07/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/25/2020	08/04/2023

Labeler - Relax Time, Inc. (084079435)

Revised: 8/2023

Document Id: 021025a3-355b-9c62-e063-6294a90a3181

34390-5

Set id: ab2878a9-5f9d-79ec-e053-2995a90adf97

Version: 3

Effective Time: 20230803