Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Sambria Pharmaceuticals Inc.
TOPICAL
OTC DRUG
For temporary relief of pain and itching due to minor skin irritation.
OTC monograph not final
PREMIUM HEMP PAIN RELIEF- LIDOCAINE, MENTHOL CREAM SAMBRIA PHARMACEUTICALS INC. _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._ ---------- PREMIUM HEMP PAIN RELIEF _DRUG FACTS_ _ACTIVE INGREDIENTS_ Lidocaine 4.0% Menthol 1% _PURPOSE_ External Analgesic _USES_ For temporary relief of pain and itching due to minor skin irritation. _WARNINGS_ FOR EXTERNAL USE ONLY AVOID CONTACT WITH EYES DO NOT USE in large quantities, particularly over raw surfaces or blistered areas STOP USE AND ASK DOCTOR IF Condition worsens or, if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use. KEEP OUT OF REACH OF CHILDREN If product is swallowed get medical help or contact a Poison Control Center right away. _DIRECTIONS_ For adults and children two-years or older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 30 to 60 seconds. _INACTIVE INGREDIENTS_ Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine, Full Spectrum Hemp Extract _OTHER INFORMATION_ Protect this product from excessive heat and direct sun. _QUESTIONS OR COMMENTS?_ FDA Registered: NDC No. 54723 info@sambriapharma.com PACKAGE LABELING: PREMIUM HEMP PAIN RELIEF lidocaine, menthol cream PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:54723-201 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 40 mg in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - Läs hela dokumentet