Lantiseptic Protective Ointment

Lantiseptic Protective by

Drug Labeling and Warnings

Lantiseptic Protective by is a Otc medication manufactured, distributed, or labeled by Santus LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LANTISEPTIC PROTECTIVE- petrolatum ointment 
Santus LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lantiseptic Protective Ointment

Drug Facts

Active Ingredient

Petrolatum 43%

Purpose

Skin Protectant

Uses

Temporarily protects minor cuts, scrapes and burns. Temporarily protects and helps relieve chafed, chapped or cracked skin and lips. Helps treat and prevent incontinence associated dermatitis.

Warnings

For external use only.

Do not use

on deep or puncture wounds, animal bites and serious burns.

When using this product

do not get into eyes.

Stop use and see a doctor

if condition lasts more than 7 days.

Keep out of reach of children.

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

Directions

Gently cleanse and dry area. Apply liberally to affected area as needed.

Other Information

Store at 15-30° C (59-86°F)

Inactive Ingredients

Aloe Vera Gel, Beeswax, Disodium EDTA, DMDM Hydantoin + IPBC, Glycerin, Lanolin, Lanolin Alcohol, Mineral Oil, Purified Water, Sodium Borate, Sorbitan Sesquioleate.

Questions or Comments?

844-7SANTUS or visit www.lantiseptic.com

Package Labeling:

LANTISEPTIC PROTECTIVE 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12090-0083
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	430 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12090-0083-1	1 in 1 CARTON	04/03/2016	12/12/2019
1		250 mL 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 final	part347	03/30/2016	12/12/2019

Labeler - Santus LLC (079868223)

Revised: 1/2020

Document Id: 9d4b6a46-7358-670f-e053-2a95a90aa69a

34390-5

Set id: 15b48c95-5e03-405b-b648-3391a1fc59e1

Version: 4

Effective Time: 20200129

 

Santus LLC