FDA.reportPublic FDA data

BABY WIPE PREMIUM

Manufacturer
SHINWA INTERNATIONAL CORPORATION
Effective date
2021-05-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:45:08

Label at a glance#

ProductBABY WIPE PREMIUM
Active ingredientALOE
Label structure13 sections

Dosage and administration

Wipe the skin and let it dry naturally. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

BABY WIPE PREMIUM

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

MOISTURIZER (ALOE) , 1mL/pcs

Purpose

OTC - PURPOSE SECTION

Antiseptic,

Use

INDICATIONS & USAGE SECTION

BABY WIPE PREMIUM to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and 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.

OTC - STOP USE SECTION

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

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

  • Wipe the skin and let it dry naturally.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER
GLYCERIN
PROPYLEN GLYCOL
DISODIUM COCOAMPHODIACETATE
2-BROMO-2-NITROPROPANE 1.3-DIOL
PEG 40 HYDROGENATED CASTOR OIL
FRAGRANCE, 4-ISOPROPYL-3-METHYLPHENOL

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81889-20181889-201-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
BRONOPOL6PU1E16C9WIACT
O-CYMEN-5-OLH41B6Q1I9LIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ALOEV5VD430YW9ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c207c6b6-ae46-0868-e053-2995a90afde9c1ab396e-2479-e1d5-e053-2a95a90ab65f2021-05-11WarningsExact identifier
spl id: c207c6b6-ae46-0868-e053-2995a90afde9
spl set id: c1ab396e-2479-e1d5-e053-2a95a90ab65f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.