FDA.reportPublic FDA data

super soft cream

Manufacturer
Anicare Pharmaceuticals Pvt. Ltd.
Effective date
2020-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:38

Label at a glance#

ProductLUCKY SUPER SOFT Cocoa Butter
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

White petrolatum USP (30%)

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

■ temporarily protects minor ■ cuts ■ scrapes ■ burns ■ temporarily protects and helps relieve chapped or cracked skin ■ helps 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

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens ■ symptoms last more than 7 days or clear up and occur again in a few days

Do not use on

OTC - DO NOT USE SECTION

■ deep or puncture wounds ■ animal bites ■ serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cetearyl alcohol, ceteareth 20, glycerin, mineral oil, fragrance, benzyl alcohol, methylchloroisothaizolinone, methylisothaizolinone, titanium dioxide, citric acid, tocopheryl acetate, theobroma cacao seed butter, FDC yellow no 6, DC red no 33, FDC yellow no 5, FDC blue no 1

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043075petrolatum 30 % Topical CreamPSN1
1043075petrolatum 300 MG/ML Topical CreamSCD1
1043075petrolatum 30 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47046-170-012022-01-28C16284748780-1d6a99b3a-007b-a426-e053-dadaa90af4c2super soft cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47046-170-01LUCKY SUPER SOFTCocoa Butter127 g in 1 TUBECREAM1271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47046-170LUCKY SUPER SOFT COCOA BUTTER (WHITE PETROLATUM) CREAM [ANICARE PHARMACEUTICALS PVT. LTD.]1Legacy NDC, 1 package rows20201221_b6e17de9-16b6-2ce6-e053-2995a90a151d.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47046-17047046-170-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCOA BUTTER512OYT1CRRIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
b6e18374-9a1d-804d-e053-2995a90a07c3b6e17de9-16b6-2ce6-e053-2995a90a151d2020-12-20WarningsExact identifier
spl id: b6e18374-9a1d-804d-e053-2995a90a07c3
spl set id: b6e17de9-16b6-2ce6-e053-2995a90a151d

Reported adverse events (FAERS/openFDA)#

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