FDA.reportPublic FDA data

Dr. Sayman Salve

Manufacturer
Sheffield Pharmaceuticals LLC
Effective date
2023-10-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:57:32

Label at a glance#

ProductDr. Sayman Salve
Active ingredientPETROLATUM, ZINC OXIDE
Label structure9 sections

Indications and uses

Temporarily protects minor cuts,scrapes and burns. Helps releive chapped or cracked skin and lips. Helps protectfrom the drying effects of windand cold weather.  Providesminimalportection agaisnt sunburn. Helps prevent sunburn.

Dosage and administration

Apply liberally before exposureand as needed Children under 6 months of age:ask a doctor Reapply as needed or after towel drying,swimming

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum - 87.3 %

Zinc Oxide- 8.8% 

Purpose 

OTC - PURPOSE SECTION

Skin protectant

Sunscreen 

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects minor cuts,scrapes and burns.
  • Helps releive chapped or cracked skin and lips.
  • Helps protectfrom the drying effects of windand cold weather. 
  • Providesminimalportection agaisnt sunburn.
  • Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only 

Sun Alert: limiting sun exposure,wearing protectvie clothing,and usingsunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if condition worsens or symptoms last more than seven days or clear up and occur again within a few days.
  • Don't use on deep/ puncture wounds,animal bites or serious burns.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally before exposureand as needed
  • Children under 6 months of age:ask a doctor
  • Reapply as needed or after towel drying,swimming

Other information 

OTHER SAFETY INFORMATION

Store at controlled room temperature 20°C -25°C (68°F - 77°F)

Inactive ingredients 

INACTIVE INGREDIENT SECTION

Lanolin, Propylene Glycol, Fragrance, Quaternium-15

Principal Display Panel -Jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Sayman's Salve       NDC 11527-152-68

Healing Salve

Ideal for Dry, Chapped or Irritated skin

Also for minor cut,scrapes and burns

NET WT 4 oz (113g)

Healing Salve jar label.jpgHealing Salve jar label.jpg

Principal Display Panel -Carton 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Sayman's Salve         NDC 11527-152-68

Healing Salve

Ideal for Dry, Chapped or Irritated Skin

Also for minor cuts, scapes and burns

NET WT 4 oz (113g)

Healing Salve carton.jpgHealing Salve carton.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
637149petrolatum 87 % / zinc oxide 8.8 % Topical OintmentPSN2
637149petrolatum 0.87 MG/MG / zinc oxide 0.088 MG/MG Topical OintmentSCD2
637149Petrolatum 0.87 MG/MG / ZNO 0.088 MG/MG Topical OintmentSY2
637149petrolatum 87 % / zinc oxide 8.8 % Topical OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-152-68Dr. Sayman Salve113 g in 1 JAROINTMENT1132
11527-152-68Dr. Sayman Salve1 in 1 CARTONOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-152DR. SAYMAN SALVE (SALVE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20231025_18bdcd0c-9c81-47e1-ae24-2239ff8fd066.zip

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
11527-15211527-152-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
ZINC OXIDESOI2LOH54ZACTIM
LANOLIN7EV65EAW6HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
QUATERNIUM-15E40U03LEM0IACT

Source Document#

Source XML · Source PDF

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
Dr. Sayman SalveSALVESheffield Pharmaceuticals LLC18bdcd0c-9c81-47e1-ae24-2239ff8fd0662023-10-24WarningsExact identifier
ndc (package): 11527-152-68
ndc (product): 11527-152
ndc11 (package): 11527015268
spl id: c45b2ae3-b31c-4ac3-8f89-fc8a60d7fd99
spl set id: 18bdcd0c-9c81-47e1-ae24-2239ff8fd066

Reported adverse events (FAERS/openFDA)#

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