75109-512 75% alcohol Digcare Alcohol Wipes

Digcare Alcohol Wipes by

Drug Labeling and Warnings

Digcare Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Kangna (Zhejiang) Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIGCARE ALCOHOL WIPES- alcohol cloth 
Kangna (Zhejiang) Medical Supplies Co., Ltd.

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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75109-512 75% alcohol Digcare Alcohol Wipes

Active Ingredient

Ethanol 75% by volume

Purpose

Antiseptic

USE

for hand sanitizing to decrease bacteria on the skin

apply topically to the skin to help prevent cross contamination

recommended for repeated use

dries in seconds

Warning

Flammable. Keep away from fire or flame. For external use only.
Do not use in or near the eyes.
Discontinue use if irritation and redness develop. If condition
persists for more than 72 hours, consult a physician.

Keep out of reach of children unless under adult supervision.

If swallowed, get medical help or call Poison Control Center immediately.

Directions

●Open lid, gently pull back resealable label, remove and use
wipe as required.
●Reseal back after use to avoid evaporation of alcohol.

Inactive ingredients

Purified Water

DIGCARE ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75109-512
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75109-512-01	50 in 1 BAG	06/10/2020
1		270 mL in 1 POUCH; 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	06/10/2020

Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)

Establishment
Name	Address	ID/FEI	Business Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.		554530173	manufacture(75109-512)

Revised: 1/2022

Document Id: d5877990-9eb3-474d-e053-2995a90aa842

34390-5

Set id: a9d83763-dd65-5d30-e053-2995a90a1350

Version: 2

Effective Time: 20220114

 

Kang