FDA.reportPublic FDA data

FDS intimate Whole Body Medicated Chafing Ointment

Manufacturer
WellSpring Pharmaceutical Corporation
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:45

Label at a glance#

ProductFDS intimate Whole Body Medicated Chafing
Active ingredientLANOLIN, PETROLATUM
Label structure10 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin

Dosage and administration

apply as needed

Storage and handling

store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lanolin 15.5%

Petrolatum 53.4%

Purpose 

OTC - PURPOSE SECTION

Skin protectant

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

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 within a few days

Do not use on

SPL UNCLASSIFIED 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

Other information

STORAGE AND HANDLING SECTION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

mineral oil, paraffin, microcrystalline wax, cod liver oil (contains vitamin A & vitamin D), fragrance

Questions?

OTC - QUESTIONS SECTION

1-844-241-5454 or FDSforHer.com

Distributed by:

SPL UNCLASSIFIED SECTION

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243

© 2024 WellSpring Pharmaceutical Corporation

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDS intimate Whole Body Medicated Chafing Ointment 1.5 oz (42.5g)

HELPS PREVENT AND TREAT Chafing

Enriched with Vitamins A+D

Non-Irritating

Odor Control Technology

NET WT 1.5 oz (42.5g)

CT70030B

NDC# 65197-730-15

CT70030B
CT70030B

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65197-73065197-730-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HACTIB
PETROLATUM4T6H12BN9UACTIB
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
COD LIVER OILBBL281NWFGIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-02-03full-release2026-06-01 00:54:25

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
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
ndc (package): 65197-730-15
ndc (product): 65197-730
ndc11 (package): 65197073015
spl id: 6657c175-174e-4843-9152-fc3e3fddeb72
spl set id: ef01fcd8-2fe4-4076-a4d4-e730a5c2b31c

Reported adverse events (FAERS/openFDA)#

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