Label: MENTHOLATUM ORIGINAL- camphor, menthol ointment
- NDC Code(s): 10742-0002-1, 10742-0002-2, 10742-0002-3, 10742-0002-4
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 7, 2023
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- Active ingredients
- Purpose
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Warnings
For external use only
When using this product
- do not get into eyes
- do not apply to wounds or to damaged skin
- do not bandage tightly
- do not heat, microwave, or add to hot water as this may cause splattering and result in burns
- Directions
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
MENTHOLATUM ORIGINAL
camphor, menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 90 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 13 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-0002-1 1 in 1 CARTON 12/01/2014 1 28 g in 1 JAR; Type 0: Not a Combination Product 2 NDC:10742-0002-2 1 in 1 CARTON 12/01/2014 2 85 g in 1 JAR; Type 0: Not a Combination Product 3 NDC:10742-0002-3 1 in 1 CARTON 10/19/2020 3 34 g in 1 JAR; Type 0: Not a Combination Product 4 NDC:10742-0002-4 1 in 1 CARTON 10/19/2020 4 102.1 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 not final part348 12/01/2014 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-0002)