Label: LUSTI PROFESIONAL VAPORIZING RUB- camphor,eucalyptus oil, menthol ointment
- NDC Code(s): 49681-012-03
- Packager: New Life Products, Inc.
- 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 2, 2023
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- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- Uses
- WARNINGS SECTION
- OTC - DO NOT USE SECTION
- OTC - ASK DOCTOR SECTION
- OTC - WHEN USING SECTION
- OTC - STOP USE SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- OTC - QUESTIONS SECTION
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DIRECTIONS
See important warnings under "When using this product". Adults and children 2 years and older, rub on throat and chest in a thick layer. Cover with a warm dry cloth if desired. Clothing should be loose about throat and chest to help vapors reach the nose and mouth. Use up to three times daily or as directed by a doctor. Children under 2 years of age: Ask a doctor.
- INACTIVE INGREDIENT SECTION
- STORAGE AND HANDLING SECTION
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PACKAGE LABEL.
Lusti Professional Vaporizing Rub
Medicated Cough suppressantTopical analgesic
Relieves minor muscle aches and pains
Net Wt. 4 Oz. (113g)Drug Facts
Active ingredients Purpose Camphor 4.8% Cough suppressant & topical analgesic Eucalyptus oil 1.2% Cough suppressant Menthol 2.6% Cough suppressant & topical analgesic Uses
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On chest an throat, temporarily relieves cough due to common cold
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On muscles and joints, temporarily relieves minor aches and pains
Warnings
For external use only; avoid contact with eyes
Do not use- By mouth
- With tight bandages
- In nostrils
- On wounds or damaged skin
Ask a doctor before use if you have
- A cough that occurs with too much phlegm (mucus)
- Persistant or chronic cough such 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 spattering and result in burns
Stop use an ask a doctor if
- Muscle aches and pain persist for more than 7 days or come back
- Cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistant headache.
These could be signs of a serious condition.
If pregnant or breast feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediatelySee important warnings under "When using this product"
- Adults and children 2 years and older
- Rub on throat and chest in a thick layer
- Cover with a warm dry cloth if desired
- Clothing should be loose about throat and chest to help vapors reach the nose and mouth
- Use up to three times daily or as directed by a doctor
- Children under 2 years of age: Ask a doctor.
Other information store at room temperature
Inactive ingredients: petrolatum, mineral oil, cedarleaf oil, nutmeg oil, spirits of turpentine, thymol
Questions or comments? www.jflbeautyclub.com
800-262-2326 or 773-838-1336Made in USA
JF LABS, INC. Chicago, Illinois 60629 -
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INGREDIENTS AND APPEARANCE
LUSTI PROFESIONAL VAPORIZING RUB
camphor,eucalyptus oil, menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49681-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) .048 g in 1 g EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL .012 g in 1 g MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM .026 g in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) MINERAL OIL (UNII: T5L8T28FGP) CEDAR LEAF OIL (UNII: BJ169U4NLG) NUTMEG OIL (UNII: Z1CLM48948) TURPENTINE (UNII: XJ6RUH0O4G) THYMOL (UNII: 3J50XA376E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49681-012-03 113 g in 1 JAR; Type 0: Not a Combination Product 08/04/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/04/2010 Labeler - New Life Products, Inc. (117815140) Establishment Name Address ID/FEI Business Operations New Life Products, Inc. 117815140 MANUFACTURE(49681-012)