CARE PLUS 1 LLC ADVANCED HAND SANITIZER WIPES- alcohol cloth

CARE Plus 1 LLC by

Drug Labeling and Warnings

CARE Plus 1 LLC by is a Otc medication manufactured, distributed, or labeled by Zhejiang Tianbo Daily Necessities Co. Ltd, Care + 1 LLC, Zhejiang Tianbo Daily Necessities Co. ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

For external use only. Flammable, keep away from heat and flames

WHEN USING

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.

STOP USE

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

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

Directions

Open lid, pull back resealable label, remove a wipe for use. Reseal back after use to avoid evaporation of alcohol.

Other information

• Dispose of wipe in the proper container.
• Do not flush down the toilet.
• Store between 59-86F (15-30C)

Inactive ingredients

Water (aqua), Glycerin, Aloe Barbadensis Leaf Juice (Alose Vera) and Tocopheryl Acetate (Vitamin E)

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

CARE PLUS 1 LLC  ADVANCED HAND SANITIZER WIPES
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79901-003
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
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79901-003-01	10 mL in 1 BAG; Type 0: Not a Combination Product	02/16/2021
2	NDC: 79901-003-02	20 mL in 1 BAG; Type 0: Not a Combination Product	02/16/2021
3	NDC: 79901-003-03	50 mL in 1 BAG; Type 0: Not a Combination Product	02/16/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/16/2021

Labeler - Zhejiang Tianbo Daily Necessities Co. Ltd (554539553)

Registrant - Care + 1 LLC (044686753)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Tianbo Daily Necessities Co. ltd		554539553	manufacture(79901-003)