Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Natures Formulae Health Products Ltd.
TOPICAL
OTC DRUG
Purpose Topical Analgesic Uses For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites. - if epileptic - with high blood pressure condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
OTC monograph not final
PAIN RELEASE- MENTHOL LIQUID NATURES FORMULAE HEALTH PRODUCTS LTD. _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._ ---------- PAIN RELEASE TOPICAL ANALGESIC MIST (100 ML) _DRUG FACTS _ _ACTIVE INGREDIENT_ Menthol 0.25% _PURPOSE_ Topical Analgesic _USES_ For the temporary relief of pain and itching associated with minor cuts, scrapes, or insect bites. _WARNINGS_ FOR EXTERNAL USE ONLY. DO NOT USE if epileptic with high blood pressure WHEN USING THIS PRODUCT, avoid contact with the eyes 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. IF PREGNANT OR BREAST-FEEDING, do not use this product. KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Not recommended for children under 12 years of age. _INACTIVE INGREDIENTS_ Anthemis nobilis flower oil, eucalyptus oil, lavender oil, melaleuca leucadendron cajaput oil, origanum majorana leaf oil, peppermint oil, rosmarinus officinalis (rosemary) leaf oil, and water. _QUESTIONS?_ 1-877-275-7253 Distributed by: SAJE NATURAL WELLNESS 500-88 E. Pender St. Vancouver, BC Canada V6A 3X3 | saje.com | 1-877-275-7253 | Made by our friends in Canada DO NOT USE IF SECURITY SEAL AROUND CAP AND BOTTLE'S NECK IS BROKEN OR MISSING SKU 376701 We support recycling. Please recycle where possible. PAIN RELEASE TOPICAL ANALGESIC MIST (100 ML) Saje® Natural Wellness PAIN RELEASE TOPICAL ANALGESIC MIST 3.4 fl. oz. | 100 ml PAIN RELEASE menthol liquid PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 20 4-0 11 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MENTHO L (UNII: L7T10 EIP3A) Read the complete document