PURE CARE -ALCOHOL WIPES

Manufacturer
Jinhua Huihuang Non-woven Products Co., Ltd. | Gourmet Home Products, LLC
Effective date
2020-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:01

Key Label Information#

Active Ingredients And Purpose

Active Ingredient(s)

Isopropyl alcohol 75% v/v

Purpose

Antiseptic

Uses

Use

Wipe surface to help reduce bacteria that can potentially cause disease.

Warnings

Warnings

For external use only. Flammable, Keep away from heat or flame.

Do not use

In children less than 2 month of age On open skin wounds

Directions And Dosage

Directions

Remove and unfold wipe Wipe surface thoroughly Dispose of used wipe in trash, do not flush

Other Label Information

Other information

Store between 50-86℉(15-30℃) Avoid freezing and excessive heat above 104℉(40℃)

Inactive ingredients

Purified water

Package Label - Principal Display Panel

100pcs NDC: 54016-020-12

Label Images#

100pcs_1
100pcs_1
100pcs_2
100pcs_2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2287160isopropyl alcohol 75 % Medicated PadPSN1
2287160isopropyl alcohol 0.75 ML/ML Medicated PadSCD1
2287160isopropyl alcohol 75 % Topical ClothSY1
2287160isopropyl alcohol 75 % Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54016-020-122022-01-28C16284748780-1d6a99b39-66e7-a426-e053-dadaa90af4c2PURE CARE -ALCOHOL WIPES 100pcs 54016-020-12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54016-020-12PURE CARE -ALCOHOL WIPES5.5 mL in 1 PATCHCLOTH5.51
54016-020-12PURE CARE -ALCOHOL WIPES100 in 1 PACKETCLOTH1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54016-020PURE CARE -ALCOHOL WIPES CLOTH [JINHUA HUIHUANG NON-WOVEN PRODUCTS CO., LTD.]1Legacy NDC, 2 package rows20201211_b619f275-9db3-eefb-e053-2a95a90aa2df.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54016-02054016-020-12

Ingredients#

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Complete SPL Sections#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl alcohol 75% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Wipe surface to help reduce bacteria that can potentially cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable, Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

In children less than 2 month of age On open skin wounds

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

When using this product, Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes with water.

OTC - STOP USE SECTION

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be sign of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Remove and unfold wipe Wipe surface thoroughly Dispose of used wipe in trash, do not flush

Other information

STORAGE AND HANDLING SECTION

Store between 50-86℉(15-30℃) Avoid freezing and excessive heat above 104℉(40℃)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100pcs NDC: 54016-020-12

Source Document#

Source XML