AKTIVE SANITIZING WIPES- ethanol alcohol 75% swab 
Gertex Hosiery

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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Aktive Sanitizing Wipes

Active Ingredient

Ethanol Alcohol 75%

Purpose

Sanitize

Uses

Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For External use only. Flammable. Keep away from heat or flame.

Do not use


On children less than 2 months old of age

On open skin wounds

When using this product

Keep out of eyes, ears, mouth. 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.

­­­­­­­­­­­­­­­­­­­­­Directions

-Wet area thoroughly with wipe. Allow to dry without rinsing.

-Supervise children under 6 years of age when using this product.

Other Information

Store at room temperature 15-30C (59-86F).

Avoid freezing and excessive heat above 40C (104 F)

Inactive Ingredients

Purified Water

Aktive Sanitizing Wipes

wipes

AKTIVE SANITIZING WIPES 
ethanol alcohol 75% swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78164-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78164-100-5050 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
2NDC:78164-100-055 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
3NDC:78164-100-1010 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
4NDC:78164-100-2525 in 1 POUCH; Type 0: Not a Combination Product05/01/2020
5NDC:78164-100-3030 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
6NDC:78164-100-4040 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
7NDC:78164-100-7575 in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug05/01/2020
8NDC:78164-100-8080 in 1 POUCH; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/01/2020
Labeler - Gertex Hosiery (201658481)
Registrant - Gertex Hosiery (201658481)

Revised: 5/2020
Document Id: a67ff02b-ed0d-1790-e053-2995a90a31fd
Set id: a67ff02b-ed0c-1790-e053-2995a90a31fd
Version: 1
Effective Time: 20200525
 
Gertex Hosiery