1ST RELIEF TOPICAL- lidocaine and menthol spray

1st RELIEF TOPICAL by

Drug Labeling and Warnings

1st RELIEF TOPICAL by is a Otc medication manufactured, distributed, or labeled by 1st Class Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Lidocaine 4.00%

Menthol 1.00%

PURPOSE

Topical Analgesic

Topical Analgesic

Indications:

For temporary relieft of pain associated with minor burns, minor cuts, scrapes, insect bites or skin irritations.

Warnings:

• For external use only
• Avoid contact with eyes
• Do not apply to open wounds or damages skin.

STOP USE

• If symptoms persist for more than seven days, discontinue use and consult physician.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed, conslut physician.

Directions

• Apply directly to affected area. Do not use more than four times per day. Children under two-years of age: consult a physician.

Other Ingredients:

Aqua (Deionized Water), ARNICA MONTANA,BOSWELLIA SERRATA, CETYL MYRISTOLEATE, EMU OIL, GLYCYRRHIZA GLABRA, METHYLSULFONYLMETHANE (MSM), POLYSORBATE 20, POTASSIUM SORBATE, SD-Alcohol 40B, SODIUM BENZOATE

PREGNANCY OR BREAST FEEDING

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

Package Label

NDC: 69094-226-04

1st Class

PHARMACEUTICALS INC.

1st RELIEF

TOPICAL SPRAY

For temporary relief of:

  backache bruises arthritis sprains

4 Fl OZ. (118 ml)

Distributed by:

1st Class PHARMACEUTICALS INC.

Los Angeles, CA 90064

www.1stclass pharmaceuticals.com

INGREDIENTS AND APPEARANCE

1ST RELIEF TOPICAL 
lidocaine and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69094-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)
CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)
EMU OIL (UNII: 344821WD61)
GLYCYRRHIZA GLABRA LEAF (UNII: GH32M797Y9)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69094-226-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/02/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/02/2014

Labeler - 1st Class Pharmaceuticals, Inc. (079448685)