MENTHOLATUM MEDICATED LIP BALM  ORIGINAL- dimethicone, octinoxate, octisalate ointment 
The Mentholatum Company

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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Drug Facts

Active ingredients

Dimethicone 1%

Octinoxate 7.5%

Octisalate 5%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use

on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

fragrance, lanolin, menthol, mineral oil, ozokerite, petrolatum

Questions?

Toll free 1-877-636-2677

MON-FRI 9 AM to 5 PM (EST)

Principal Display Panel

Mentholatum Medicated Lip Balm Original

Principal Display Panel

Drug Facts
MENTHOLATUM MEDICATED LIP BALM   ORIGINAL
dimethicone, octinoxate, octisalate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8865
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE10 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
MINERAL OIL (UNII: T5L8T28FGP)  
CERESIN (UNII: Q1LS2UJO3A)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8865-11 in 1 BLISTER PACK08/01/2016
14.2 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:10742-8865-33 in 1 BLISTER PACK10/01/2018
24.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/2016
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8865)

Revised: 2/2023
Document Id: f41f7012-5358-5635-e053-2a95a90af021
Set id: f84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df1
Version: 3
Effective Time: 20230207
 
The Mentholatum Company