Lantiseptic Original Skin Protectant Cream

Lantiseptic Original Skin Protectant by

Drug Labeling and Warnings

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

Drug Details [pdf]

LANTISEPTIC ORIGINAL SKIN PROTECTANT- lanolin cream 
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 Original Skin Protectant Cream

Active Ingredient

Lanolin USP 50%

Purpose

Skin Protectant

Uses

Helps prevent and treat skin irritations. Protects chafed skin or minor skin irritations due to incontinence Helps seal out wetness.

Warnings

For external use only. Avoid contact with eyes. Do not apply to deep or puncture wounds. If condition worsens, or does not improve within 7 days, consult a doctor. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

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

Beeswax (Yellow Wax), Disodium EDTA, DMDM Hydantoin + IPBC, Lanolin Alcohol, Mineral Oil, Petrolatum, Purified Water, Sodium Borate, Sorbitan Sesquioleate.

Questions or Comments?

844-7SANTUS or visit www.lantiseptic.com

Package Labeling:

LANTISEPTIC ORIGINAL SKIN PROTECTANT 
lanolin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12090-0019
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
YELLOW WAX (UNII: 2ZA36H0S2V)	Â
EDETATE DISODIUM (UNII: 7FLD91C86K)	Â
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)	Â
MINERAL OIL (UNII: T5L8T28FGP)	Â
PETROLATUM (UNII: 4T6H12BN9U)	Â
WATER (UNII: 059QF0KO0R)	Â
SODIUM BORATE (UNII: 91MBZ8H3QO)	Â
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12090-0019-6	5 g in 1 PACKET; Type 0: Not a Combination Product	03/03/2016	12/12/2019
2	NDC: 12090-0019-1	14.2 g in 1 PACKET; Type 0: Not a Combination Product	03/03/2016	12/12/2019
3	NDC: 12090-0019-3	113 g in 1 TUBE; Type 0: Not a Combination Product	03/03/2016	12/12/2019
4	NDC: 12090-0019-4	130 g in 1 JAR; Type 0: Not a Combination Product	03/03/2016	12/12/2019
5	NDC: 12090-0019-7	1 in 1 CARTON	03/03/2016	12/12/2019
5		340 g in 1 JAR; 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	03/03/2016	12/12/2019

Labeler - Santus LLC (079868223)

Revised: 1/2020

Document Id: 9d4b5967-cb24-0e61-e053-2a95a90a5c0b

34390-5

Set id: daefbb0e-7650-4f35-b337-14a10f869ae2

Version: 5

Effective Time: 20200129

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