Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
FAMILY DOLLAR (Family Wellness)
TOPICAL
OTC DRUG
Topical Analgesic Topical Analgesic For temporary relief of minor aches and pains of muscle and joints associated with; - simple backaches, arthritis, strains, bruises and sprains - condition worsens or symptoms persist for more than 7 days - symptoms clear up and occur again within a few days - excessive skin irritation occur
OTC monograph not final
FAMILY WELLNESS HOT AND COLD PAIN RELIEF- HOT AND COLD PAIN RELIEF CREAM FAMILY DOLLAR (FAMILY WELLNESS) _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._ ---------- FAMILY WELLNESS HOT AND COLD PAIN RELIEF DRUG FACTS ACTIVE INGREDIENTS Menthol - 10% Methyl salicylate -30% PURPOSE Topical Analgesic Topical Analgesic USES For temporary relief of minor aches and pains of muscle and joints associated with; simple backaches, arthritis, strains, bruises and sprains WARNING FOR EXTERNAL USE ONLY DO NOT USE on wounds or damaged skin with a heating pad on a child under 12 years of age with arthritis-like condiitions ASK A DOCTOR BEFORE USE IF YOU HAVE; redness over thre affected area WHEN USING THIS PRODUCT avoid contact with eyes and mucous membranes do not bandage tightly STOP USE AND ASK A DOCTOR IF; condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive skin irritation occur KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center immediately. DIRECTIONS Use only as directed 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; ask a doctor. OTHER INFORMATION Store at controlled room temperature 20°- 25°C ( 68° to 77°F) INACTIVE INGREDIENTS QUESTIONS? 1-800 814-8028 PRINCIPAL DISPLAY PANEL -TUBE Family Wellness NDC 55319-824-35 Cold & Hot Pain Relief Cream MENTHOL 10% METHYL SALICYLATE 30% NET WT 1.25 OZ (35.4g) PRINCIPAL DISPLAY PANEL -CARTON Family Wellness NDC 55319-824-35 Cold & Hot Pain Relief Cream MENTHOL 10% METHYL SALICYLATE 30% NET WT 1.25 OZ (35.4g) FAMILY WELLNESS HOT AND COLD PAIN RELIEF hot and cold pain relief cream PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:55319-824 ROUTE OF ADMINISTRATION TOPICAL FAMILY DO Read the complete document