ALCOHOL WET WIPES: Package Insert and Label Information

ALCOHOL WET WIPES- alcohol cloth
CB Shelton Enterprises Llc.

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.

Active Ingredient

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable, keep away from heat and flames. When using this product, Avoid contact with eyes.

In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

Open the resealable sticker on the top and remove a wipe for use. When needed, rub/wipe vigorously on hands, between fingers, at fingernails, and then scrub wrists and forearms. After use, reseal the sticker on top to avoid evaporation of alcohol.

Other Information

● Dispose of wipe in the proper receptacle.

● Do not flush down the toilet.

● Store between 59-86 F (15-30 C).

Inactive Ingredient

Water

1 Wipe, NDC: 81987-001-01

ALCOHOL WET WIPES alcohol wet wipes cloth

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81987-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:81987-001-01 1 APPLICATOR in 1 BAG contains a APPLICATOR 1 2 mL in 1 APPLICATOR This package is contained within the BAG (81987-001-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2021

Labeler — CB Shelton Enterprises Llc. (080023696)

Registrant — LINGHAI ZHANWANG BIOTECHNOLOGY CO.,LTD. (560972943)

Establishment
Name	Address	ID/FEI	Operations
LINGHAI ZHANWANG BIOTECHNOLOGY CO.,LTD.		560972943	manufacture (81987-001)

Revised: 12/2022 CB Shelton Enterprises Llc.