FDS INTIMATE WHOLE BODY MEDICATED CHAFING ointment

FDS intimate Whole Body Medicated Chafing by

Drug Labeling and Warnings

FDS intimate Whole Body Medicated Chafing by is a Otc medication manufactured, distributed, or labeled by WellSpring Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lanolin 15.5%

Petrolatum 53.4%

Purpose 

Skin protectant

Skin protectant

Uses

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

Warnings

For external use only

When using this product

• do not get into eyes

Stop use and ask a doctor if

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

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children

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

Directions

apply as needed

Other information

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

Inactive ingredients

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

Questions?

1-844-241-5454 or FDSforHer.com

Distributed by:

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243

© 2024 WellSpring Pharmaceutical Corporation

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)

CT70030A

NDC# 65197-730-15

P13058.00

FDS intimate Whole Body Medicated Chafing Ointment1.5 oz (42.5g)

INGREDIENTS AND APPEARANCE

FDS INTIMATE WHOLE BODY MEDICATED CHAFING 
fds intimate whole body medicated chafing ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65197-730
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	15.5 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	53.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
COD LIVER OIL (UNII: BBL281NWFG)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65197-730-15	1 in 1 BOX	01/31/2025
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	01/31/2025

Labeler - WellSpring Pharmaceutical Corporation (110999054)