Label: MENTHOLATUM GREASELESS VAPORIZING CREAM- camphor, eucalyptus oil, menthol cream
- NDC Code(s): 10742-0003-1
- Packager: The Mentholatum Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
-
Warnings
For external use only
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts or as occurs with smoking, asthma, or emphysema
When using this product, do not
- heat
- microwave
- add to hot water or any container where heating water. May cause splattering and result in burns.
- do not take by mouth or place in nostrils
- do not bandage tightly
- do not get into eyes
- do not apply to wounds or damaged skin
Stop use and ask a doctor if
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
- muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days
- Keep Out of Reach of Children
-
Directions
- see important warnings under "When using this product"
- adults and children 2 years and over:
- for cough suppression -
- rub a thick layer on the throat and chest
- cover with a warm, dry cloth if desired
- keep clothing loose about the throat and chest to help vapors reach the nose and mouth
- use up to 3 times daily or as directed by a doctor
- for muscle / joint minor aches and pains apply to affected area not more than 3 to 4 times daily
- children under 2 years : ask a doctor
- Inactive ingredients
- Questions
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
MENTHOLATUM GREASELESS VAPORIZING CREAM
camphor, eucalyptus oil, menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 53 mg in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL 13 mg in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 28 mg in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) CHLORPHENESIN (UNII: I670DAL4SZ) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) GLYCERIN (UNII: PDC6A3C0OX) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL) MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-0003-1 1 in 1 CARTON 07/15/2019 1 50 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/15/2019 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-0003)
