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
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)  
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)  
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
2 NDC:12090-0019-1 14.2 g in 1 PACKET; Type 0: Not a Combination Product
3 NDC:12090-0019-3 113 g in 1 TUBE; Type 0: Not a Combination Product
4 NDC:12090-0019-4 130 g in 1 JAR; Type 0: Not a Combination Product
5 NDC:12090-0019-7 1 in 1 CARTON
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
Labeler - Santus LLC (079868223)

Revised: 3/2016
Document Id: 2d3fd7bb-44d1-1429-e054-00144ff8d46c
Set id: daefbb0e-7650-4f35-b337-14a10f869ae2
Version: 3
Effective Time: 20160304
 
Santus LLC