Pain Crush by Genexa Inc. PAIN CRUSH- menthol gel

Pain Crush by

Drug Labeling and Warnings

Pain Crush by is a Otc medication manufactured, distributed, or labeled by Genexa Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient +

Menthol 7%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

WARNINGS

Warnings

For external use only.

Flammable. Keep away from fire or flame.

DO NOT USE

Do not use

• on wounds or damaged skin
• on a child under 12 years of age with arthritis-like conditions

ASK DOCTOR

Ask a doctor before use if you have redness over the affected area.

WHEN USING

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly or use with a heating pad

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• excessive skin irritation occurs

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• shake well before each use
• adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• store between 20 to 25°C (68 to 77°F)
• close cap tightly after use
• see bottom of bottle for Lot No. and Exp. Date.

INACTIVE INGREDIENT

Inactive ingredients

organic aloe vera leaf juice, organic ethyl alcohol, organic glycerin, organic licorice root extract, organic peppermint oil, purified water (aqua), xanthan gum

SPL UNCLASSIFIED SECTION

+Certified Organic, free of parabens, dyes, petroleum and genetically modified organisms

Distributed by: Genexa Inc., Beverly Hills, CA 90211 www.genexa.com

Questions? 1-855-GENEXA-1

Certified Organic by SCS Global Services

MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

PRINCIPAL DISPLAY PANEL

Genexa®

COLD THERAPY PAIN RELIEF ROLL ON

PAIN CRUSH™

Menthol / Topical Analgesic

3 FL OZ (89 mL)

Back Pain + Arthritis / Sore Muscles + Joints / Shoulder + Leg Pain

USDA ORGANIC

NON GMO Project VERIFIED

FREE OF DYES & PARABENS

NDC: 69676-0004-6

INGREDIENTS AND APPEARANCE

PAIN CRUSH 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69676-0004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
ALCOHOL (UNII: 3K9958V90M)
LICORICE (UNII: 61ZBX54883)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69676-0004-6	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	06/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/13/2018

Labeler - Genexa Inc. (079751024)