AURORAE HEALING PAIN RELIEVING ROLL-ON- menthol solution

Aurorae Healing Pain Relieving Roll-On by

Drug Labeling and Warnings

Aurorae Healing Pain Relieving Roll-On by is a Otc medication manufactured, distributed, or labeled by Ingui Design, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Menthol 10.00%

Purpose

External Analgesic

Uses

for temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Warnings

• For external use only.
• Avoid contact with eyes
• Do not apply to open wounds or damaged skin.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children

If swallowed consult physician.

Do not bandage tightly.

If pregnant or breast feeding consult physician prior to use.

Directions

Apply directly to affected area. Do not use more than four times per day.

Other ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gell, Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Flower Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Methyl Salicylate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

Product Label

INGREDIENTS AND APPEARANCE

AURORAE HEALING PAIN RELIEVING ROLL-ON 
menthol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69582-590
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVENDER OIL (UNII: ZBP1YXW0H8)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69582-590-01	90 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	02/04/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/04/2015

Labeler - Ingui Design, LLC (809197903)