Label: ANALGESIC- menthol spray
- NDC Code(s): 32472-102-03
- Packager: Premiere Enterprises
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
Premiere Enterprises, Inc.
- Active Ingredients
USP Menthol 7%Close
Temporary relief of minor aches and pains of muscles and joints.Close
- For external use only
- Flammable. Keep away from flame.
- Keep out of reach of children- if swallowed get medical help or contact a poison center right away.
- Avoid contact with eyes
- Do not apply to open wounds or damaged skin
- Do not bandage tightly
- Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.
For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Get extra relief by using after warm shower or bath. Will not stain clothing. For children under 2 years of age, consult a Doctor.Close
- Other Information:
Store at room temperature.Close
- Inactive Ingredients:
Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan GumClose
- 1-800-576-7616 Amazing-Solutions.com
PREMIERE ENTERPRISES, INC.
Los Angeles, CA 90034Close
- PRINCIPAL DISPLAY PANEL
A miracle in every bottle!
TEMPORARY RELIEF OF
MINOR ACHES & PAINS
ARTHRITIS ● BACKACHE
STIFF JOINTS ● SORE MUSCLES
SPRAINS ● BRUISES
NATURAL MENTHOL ● HERBAL FORMULA
Net 3 fluid oz./88 ml.Close
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:32472-102 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol 700 mL in 1 L Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) isopropyl alcohol (UNII: ND2M416302) glycerin (UNII: PDC6A3C0OX) eucalyptus oil (UNII: 2R04ONI662) methyl salicylate (UNII: LAV5U5022Y) peppermint oil (UNII: AV092KU4JH) coconut oil (UNII: Q9L0O73W7L) xanthan gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:32472-102-03 0.088 L in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/12/2011 Labeler - Premiere Enterprises (556225498) Registrant - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 MANUFACTURE