FDA.reportPublic FDA data

Tenzer

Manufacturer
Collection 2000 Cosmetics,Inc. | Vikshara Trading & Investments Ltd.
Effective date
2014-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:11

Label at a glance#

ProductTenzer Baby
Active ingredientPETROLATUM
Label structure8 sections

Indications and uses

temporarily protects minor cuts, scraps, burns temporarily protects and helps relieve chapped or cracked skin and lips helps protect from the drying effects of wind & cold weather

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum USP 100%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor
    • cuts, scraps, burns
  • temporarily protects and helps relieve chapped or cracked skin and lips
  • helps protect from the drying effects of wind & cold weather

Warnings

WARNINGS SECTION

  • For external use only

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes

See a doctor

SPL UNCLASSIFIED SECTION

  • if condition lasts more than 7 days

Do not use on

OTC - DO NOT USE SECTION

  • deep or 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

SPL UNCLASSIFIED SECTION

Distributed By :
Collection 2000 Cosmetics Inc.
Miami, Florida - 33126. USA.

PRINCIPAL DISPLAY PANEL - 284 g Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TENZER™

Petroleum Jelly

fragrance free

1
2  3

NET WT 10 Oz [284g]

PRINCIPAL DISPLAY PANEL - 284 g Container Label
PRINCIPAL DISPLAY PANEL - 284 g Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204754petrolatum 100 % Topical JellyPSN1
204754petrolatum 1 MG/MG Topical OintmentSCD1
204754petrolatum 100 % Topical JellySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69174-126-102019-11-27C16284748780-19855e2a2-4bbd-60a7-e053-dbdaa90a05bdTenzer™ Baby
69174-126-132019-11-27C16284748780-19855e2a2-4bbd-60a7-e053-dbdaa90a05bdTenzer™ Baby

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69174-126-10Tenzer Baby284 g in 1 CONTAINERJELLY2841
69174-126-13Tenzer Baby368 g in 1 CONTAINERJELLY3681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69174-126TENZER BABY (PETROLATUM) JELLY [COLLECTION 2000 COSMETICS,INC.]1Legacy NDC, 2 package rows20140912_2b177667-ad01-4575-9ca2-7adb2b75b66a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69174-12669174-126-10, 69174-126-13

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
685fa740-cc03-4508-b5a7-6a097d82597d2b177667-ad01-4575-9ca2-7adb2b75b66a2014-09-05WarningsExact identifier
spl id: 685fa740-cc03-4508-b5a7-6a097d82597d
spl set id: 2b177667-ad01-4575-9ca2-7adb2b75b66a

Reported adverse events (FAERS/openFDA)#

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