Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Prime Enterprises, Inc.
TOPICAL
OTC DRUG
Topical Analgesic For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations.
OTC monograph not final
BOTANIKA LIFE ULTRA-RELIEF PAIN RUB- LIDOCAINE, MENTHOL OIL PRIME ENTERPRISES, 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._ ---------- BOTANIKA LIFE ULTRA-RELIEF PAIN RUB _ACTIVE INGREDIENTS_ Lidocaine 4% Menthol 1% _PURPOSE_ Topical Analgesic _USES_ For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites or minor skin irritations. _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE in large quantities, particularly over raw surfaces or blistered areas. WHEN USING THIS PRODUCT avoid contact with the eyes. Use only as directed. STOP USE AND ASK A DOCTOR IF condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Posion Control Center right away. IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. _DIRECTIONS_ ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor. _INACTIVE INGREDIENTS_ Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Butyrospermum Parkii (Shea) Butter, Cannabidiol, Coconut Oil, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Olea Europaea (Olive) Fruit Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate BOTANIKA LIFE ULTRA-REPAIR PAIN RUB BOTANIKA LIFE ULTRA-RELIEF PAIN RUB lidocaine, menthol oil PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:58443-0392 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 34.24 mg in 1 mL MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 8.56 mg in 1 mL I Přečtěte si celý dokument