FDA.reportPublic FDA data

AQUA-NU

Manufacturer
Nugeri LLC
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:04:13

Label at a glance#

ProductAQUA-NU
Active ingredientPETROLATUM
Label structure1 sections

Label contents#

Full prescribing information#

Aqua-NU

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 42%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps to prevent chaffed, chapped, or cracked skin
  • Helps to prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For External Use Only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • If the condition worsens discontinue use and contact physician

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply genreously to affected areas or as directed by the physician

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15ºC - 30ºC (59ºF - 86ºF)

Inactive Ingredient Section

Ceresin Wax, Lanolin Alcohol, Mineral Oil, Paraffin Wax, & Phenoxyethanol

Container sizes

HOW SUPPLIED SECTION

Aqua-Nu 16ozAqua-Nu 16ozAqua-NU 3.5ozAqua-NU 3.5oz

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81266-91081266-910-16, 81266-910-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN ALCOHOLS884C3FA9HEIACT
CERESINQ1LS2UJO3AIACT
PARAFFINI9O0E3H2ZEIACT
LIGHT MINERAL OILN6K5787QVPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PETROLATUM4T6H12BN9UACTIB

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
0874ce98-c20f-000e-e063-6394a90afc2fb6c5c93f-6747-6960-e053-2a95a90a4b5e2023-10-24WarningsExact identifier
spl set id: b6c5c93f-6747-6960-e053-2a95a90a4b5e

Reported adverse events (FAERS/openFDA)#

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