TINFU ISOPROPYL ALCOHOL PREP PADS- isopropyl alcohol cloth

Tinfu Isopropyl Alcohol Prep Pads by

Drug Labeling and Warnings

Tinfu Isopropyl Alcohol Prep Pads by is a Otc medication manufactured, distributed, or labeled by Shandong T&F Medical Technology Co., Ltd, Shandong T&F Medical Technology 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. Isopropyl Alcohol (75%, 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)

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

For preparation of the skin prior to injection.

Warnings

For external use only. Flammable,keep away from fire or flame.

Do not use

• with electrocautery procedures.

WHEN USING

When using this product do not get into eyes. do not apply over large areas of the body. in case of deep or puncture wounds, animal bites or serious burns, consult a doctor. use only in a well ventilated area.

STOP USE

Stop use and ask a doctor if irritation and redness develops.

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If pregnant or breastfeeding ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Apply to skin as needed.
• Discard after single use.

Other information

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

Inactive ingredients

Water

Package Label - Principal Display Panel

NDC: 82167-000

INGREDIENTS AND APPEARANCE

TINFU ISOPROPYL ALCOHOL PREP PADS 
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82167-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82167-000-01	0.12 mL in 1 PATCH; Type 0: Not a Combination Product	08/25/2021
2	NDC: 82167-000-02	100 in 1 BOX	08/25/2021
2		0.12 mL in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 82167-000-03	200 in 1 BOX	08/25/2021
3		0.12 mL in 1 PACKET; Type 0: Not a Combination Product
4	NDC: 82167-000-04	300 in 1 BOX	08/25/2021
4		0.12 mL in 1 PACKET; Type 0: Not a Combination Product
5	NDC: 82167-000-05	0.25 mL in 1 PATCH; Type 0: Not a Combination Product	08/25/2021
6	NDC: 82167-000-06	100 in 1 BOX	08/25/2021
6		0.25 mL in 1 PACKET; Type 0: Not a Combination Product
7	NDC: 82167-000-07	200 in 1 BOX	08/25/2021
7		0.25 mL in 1 PACKET; Type 0: Not a Combination Product
8	NDC: 82167-000-08	300 in 1 BOX	08/25/2021
8		0.25 mL in 1 PACKET; Type 0: Not a Combination Product
9	NDC: 82167-000-09	0.56 mL in 1 PATCH; Type 0: Not a Combination Product	08/25/2021
10	NDC: 82167-000-10	100 in 1 BOX	08/25/2021
10		0.56 mL in 1 PACKET; Type 0: Not a Combination Product
11	NDC: 82167-000-11	200 in 1 BOX	08/25/2021
11		0.56 mL in 1 PACKET; Type 0: Not a Combination Product
12	NDC: 82167-000-12	300 in 1 BOX	08/25/2021
12		0.56 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 Drug	M003	08/25/2021

Labeler - Shandong T&F Medical Technology Co., Ltd (541535862)

Establishment
Name	Address	ID/FEI	Business Operations
Shandong T&F Medical Technology Co., Ltd.		541535862	manufacture(82167-000)