SOOTHE AND COOL FREE MEDSEPTIC SKIN PROTECTANT- lanolin ointment

Soothe and Cool Free Medseptic by

Drug Labeling and Warnings

Soothe and Cool Free Medseptic by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc., Dhaliwal Labs Illinois,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

• Lanolin USP: 50%

Purpose

Skin Protectant

Use

• protects and helps relieve the symptoms of minor skin irritation
• helps seal out wetness
  
• emollient

Warnings

For external use only

When using this product

• do not use in or near the eyes
  

Do not use

on

• deep or puncture wounds

• animal bites

• serious burns

Stop use and ask a doctor if

• condition worsens
  
• symptoms persist for more than 7 days, or clear upand occur again within a few days.
  

Keep out of reach of children.

If swallowed

get medical help or contact a Poison Control right away.

Directions

Gently cleanse and dry affected area.

Apply liberally to affected area as needed.

Other information

Protect from freezing.

Avoid excessive heat.

Inactive ingredients

Aloe Barbadensis Leaf Juice

Beeswax

Cholecalciferol

Disodium EDTA

Methylparaben

Oxyquinoline, Petrolatum

Propylparaben

Retinyl Palmitate

Sodium Borate

Sorbitan Sesquioleate

Tocopherol

Water

Zea Mays (Corn) Oil

Principal Display Panel

INGREDIENTS AND APPEARANCE

SOOTHE AND COOL FREE MEDSEPTIC  SKIN PROTECTANT
lanolin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H)	LANOLIN	500 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
OXYQUINOLINE (UNII: 5UTX5635HP)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)
CORN OIL (UNII: 8470G57WFM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-042-44	113 g in 1 JAR; Type 0: Not a Combination Product	01/01/2007
2	NDC: 53329-042-77	14 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2007

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Labs Illinois,LLC		079679410	manufacture(53329-042)