FDA.reportPublic FDA data

Cloverine

Manufacturer
Medtech Products Inc.
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:24:10

Label at a glance#

ProductCloverine
Active ingredientPETROLATUM
Label structure10 sections

Indications and uses

Helps prevent and temporarily protects chapped hands, face, lips minor burns windburn chafing

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cloverine® Brand Salve

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 97%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Uses

INDICATIONS & USAGE SECTION

Helps prevent and temporarily protects

  • chapped hands, face, lips
  • minor burns
  • windburn
  • chafing

Warnings

WARNINGS SECTION

For external use only.

When using this product

SPL UNCLASSIFIED SECTION

avoid contact with eyes.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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 within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

fragrance, rectified turpentine oil, white wax

Other information

SPL UNCLASSIFIED SECTION

  • do not leave exposed to heat or direct sunlight.

Questions?

OTC - QUESTIONS SECTION

1-800-443-4908

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

White
Cloverine
Brand
White petrolatum
Salve
1 oz. (28.4 g)

PRINCIPAL DISPLAY PANEL White Cloverine Brand White petrolatum Salve 1 oz. (28.4 g)PRINCIPAL DISPLAY PANEL White Cloverine Brand White petrolatum Salve 1 oz. (28.4 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-701-012020-06-26C16284748780-19d75b9d0-16f0-f424-e053-dadaa90a57ceCloverine Salve
63029-701-012020-01-31C16284748780-19d75b9d0-16f0-f424-e053-dadaa90a57ceCloverine Salve

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-70163029-701-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
TURPENTINE OILC5H0QJ6V7FIACT
YELLOW WAX2ZA36H0S2VIACT

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
314bf59c-be05-4de1-9d22-c33eb526915ea8a52238-bf6b-4562-885a-4914b7fa1f752020-06-30WarningsExact identifier
spl id: 314bf59c-be05-4de1-9d22-c33eb526915e
spl set id: a8a52238-bf6b-4562-885a-4914b7fa1f75

Reported adverse events (FAERS/openFDA)#

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