KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF- methyl salicylate, menthol, camphor liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)

Available from:

Avaria Health & Beauty Corp

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Analgesic Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints

Authorization status:

OTC monograph not final

Summary of Product characteristics

KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF- METHYL SALICYLATE, MENTHOL,
CAMPHOR LIQUID
AVARIA HEALTH & BEAUTY CORP
_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._
----------
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Camphor 3%
Menthol 8%
Methyl salicylate 15%
_PURPOSE_
Topical Analgesic
_USES_
Provides penetrating pain relief for the temporary relief of minor
aches and pains of
muscles and joints
_WARNINGS_
FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.
DO NOT USE:
• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions
WHEN USING THIS PRODUCT avoid contact with eyes or mucous membranes,
do not
bandage tightly.
STOP USE AND ASK A DOCTOR IF condition worsen or symptoms persist more
than 7
days, symptoms clear up and occur again within a few days and/or
excessive skin
irritation occurs.
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away
_DIRECTIONS_
Adults and children 12 years and over: Spray evenly onto affected
areas no more than 3
to 4 times daily. Apply spray to affected areas and
allowed to dry or thoroughly massage until penetrated. Wash hands with
soap and
water after use.
_OTHER INFORMATION_
• Store at 59°F - 77°F
_INACTIVE INGREDIENTS_
Alcohol Denat., Arnica Montana Flower Extract, Bis-Peg 12 Dimethicone,
Bis-Peg 10
Dimethicone, Water
QUESTIONS OR COMMENTS?
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PRODUCT LABEL
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEF
methyl salicylate, menthol, camphor liquid
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:43493-0010
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
15 g
in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L