Bold Wipes Hand Sanitizing Wipes by Ata International Inc. / Gurpak Ambalaj ve Gida Sanayi Tic. LTD STI

Bold Wipes Hand Sanitizing Wipes by

Drug Labeling and Warnings

Bold Wipes Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Ata International Inc., Gurpak Ambalaj ve Gida Sanayi Tic. LTD STI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BOLD WIPES HAND SANITIZING WIPES- alcohol cloth 
Ata International 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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Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria on skin only when soap and water are not available

Warnings

Flammable, keep away from heat or flame.

For external use only.

• do not use in or near the eyes
• in case of contact, rinse eyes thoroughly with water

• if irritation or rash appears and lasts

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

Directions

• Wipe hands; discard

Other information

• Store between below 110 °F (43°C)
• May discolor certain fabrics or surfaces

Inactive ingredients

Water (deionized), gylcerin, perfume

Package Label - Principal Display Panel

Bold Wipes Box - 50 Individually Packed Wipes NDC: 80217-001-50

Bold Wipes - Single Pack Wipe NDC: 80217-001-01

BOLD WIPES HAND SANITIZING WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80217-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	3.15 mL  in 4.5 mL

Inactive Ingredients
Ingredient Name	Strength
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.0675 mL  in 4.5 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.09 mL  in 4.5 mL
WATER (UNII: 059QF0KO0R)	1.1925 mL  in 4.5 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80217-001-01	4.5 mL in 1 PACKET; Type 0: Not a Combination Product	08/22/2020
2	NDC: 80217-001-50	50 in 1 BOX	08/21/2020
2	NDC: 80217-001-01	4.5 mL in 1 PACKET; 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	08/21/2020	08/27/2022

Labeler - Ata International Inc. (017653587)

Registrant - Ata International Inc. (017653587)

Establishment
Name	Address	ID/FEI	Business Operations
Gurpak Ambalaj ve Gida Sanayi Tic. LTD STI		535195127	manufacture(80217-001)

Revised: 7/2021

Document Id: c743bf55-64d4-ed8b-e053-2995a90a772e

34390-5

Set id: aca9af74-7d52-c87d-e053-2a95a90ae9fd

Version: 3

Effective Time: 20210716