LANTISEPTIC DRY SKIN THERAPY- 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 Dry Skin Therapy Cream

Drug Facts

Active Ingredient

Lanolin USP 30%

Purpose

Skin Protectant

Uses

• Helps protect ulcer prone skin. • For treatment of cracked skin, minor burns or irritations. • Helps prevent chafing and dryness.

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. • Massage liberally into affected area as needed. • Cover treated feet.

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:

Dry Skin

LANTISEPTIC DRY SKIN THERAPY 
lanolin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12090-0016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12090-0016-214.2 g in 1 PACKET; Type 0: Not a Combination Product03/02/201612/12/2019
2NDC:12090-0016-1113 g in 1 TUBE; Type 0: Not a Combination Product03/02/201612/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/02/201612/12/2019
Labeler - Santus LLC (079868223)

Revised: 1/2020
 
Santus LLC