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NDC 69582-0590-01 Aurorae Healing Pain Relieving Roll-On 100 mg/mL Details

Aurorae Healing Pain Relieving Roll-On 100 mg/mL

Aurorae Healing Pain Relieving Roll-On is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Ingui Design, LLC. The primary component is MENTHOL.

Product Information

NDC	69582-0590
Product ID	69582-590_616f96b9-4390-f9d4-e053-2a91aa0a998f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aurorae Healing Pain Relieving Roll-On
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	100
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	Ingui Design, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69582-0590-01 (69582059001)

Pricing Information	N/A
NDC Package Code	69582-590-01
Billing NDC	69582059001
Package	90 mL in 1 BOTTLE, WITH APPLICATOR (69582-590-01)
Marketing Start Date	2015-02-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4875576f-d27f-4101-b191-26dd4399ef0d Details

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Ingui Design, LLC (809197903)

Revised: 12/2017

Document Id: 616f96b9-4390-f9d4-e053-2a91aa0a998f

Set id: 4875576f-d27f-4101-b191-26dd4399ef0d

Version: 2

Effective Time: 20171228