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:

Skin Protectant

LANTISEPTIC ORIGINAL SKIN PROTECTANT
lanolin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12090-0019
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
YELLOW WAX (UNII: 2ZA36H0S2V)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/03/2016	12/12/2019

Labeler - Santus LLC (079868223)

Revised: 1/2020

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

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

Version: 5

Effective Time: 20200129

Santus LLC