SYREN INTIMATE RELIEF TOPICAL PAIN RELIEF- lidocaine hydrochloride gel

SYREN Intimate Relief Topical Pain Relief by

Drug Labeling and Warnings

SYREN Intimate Relief Topical Pain Relief by is a Otc medication manufactured, distributed, or labeled by Icon Health Science. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient:

Lidocaine HCl 4.00%

Topical Analgesic

Indications:

For the temporary relief of pain and itching, cuts, scrapes, and minor skin irritations.

Warnings:

• For external use only.
• Avoid contact with eyes.
• If symptoms persist for more than seven days discontinue use.

Keep out of reach of children.

If swallowed, consult physician.

• Do not apply to wounds or damaged skin.
• Wash hands after use.

If pregnant or breast feeding, contact physician prior to use.

Directions:

• Adults and children two-years of age or older:  Apply to affected area not more than three to four times daily.
• Children under twelve-years of age:  consult a physician.

Additional Information:

Store at room temperature.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Benzoic Acid, Cannabis Sativus (Hemp) Seed Oil, Carbomer, Carrageenan, Ethylhexylglycerin, I-Arginine, PEG-8, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tocopherol Acetate (Vitamin E), Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

SYREN INTIMATE RELIEF TOPICAL PAIN RELIEF 
lidocaine hydrochloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69233-843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69233-843-01	1 in 1 BOX	08/28/2017
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/28/2017

Labeler - Icon Health Science (079435759)