FDA.reportPublic FDA data

Health Smart Creamy Petroleum

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd
Effective date
2020-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:12

Label at a glance#

ProductHealth Smart Creamy Petroleum
Active ingredientPETROLATUM
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Petrolatum 30%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

  • temporarily protects minor; cuts, scrapes or burns.

  • temporarily protects and helps relieve chapped or cracked skin.

  • helps protect from the drying effects of wind and cold weather.

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product do not get into eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

OTC - DO NOT USE SECTION

Do not use on

  • deep puncture wounds
  • animal bites
  • serious burns

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.

DOSAGE & ADMINISTRATION SECTION

Directions

apply as needed.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water (aqua), carbopol 940, stearic acid, glyceryl monostearate, mineral oil, cetearyl alcohol, GE125 emulsifying agent, methylparaben, propylparaben, triethanolamine, tocopheryl acetate.

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

HEALTH SMART CREAMY PETROLEUM JELLY

NET WT. 4.5 OZ. (128G)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037285petrolatum 30 % Topical GelPSN1
1037285petrolatum 0.3 MG/MG Topical GelSCD1
1037285petrolatum 30 % Topical GelSY1
1037285petrolatum 30 % Topical JellySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-166-012022-01-28C16284748780-1d6a99b39-e788-a426-e053-dadaa90af4c2Health Smart Creamy Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-166-01Health Smart Creamy Petroleum128 g in 1 TUBEJELLY1281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-166HEALTH SMART CREAMY PETROLEUM (PETROLEUM) JELLY [ANICARE PHARMACEUTICALS PVT. LTD]1Legacy NDC, 1 package rows20201215_b65f1f41-b69f-fcfa-e053-2995a90a59d4.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-16647046-166-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
b65f1676-6479-5799-e053-2a95a90af504b65f1f41-b69f-fcfa-e053-2995a90a59d42020-12-13WarningsExact identifier
spl id: b65f1676-6479-5799-e053-2a95a90af504
spl set id: b65f1f41-b69f-fcfa-e053-2995a90a59d4

Reported adverse events (FAERS/openFDA)#

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