ABSORBINE JR- menthol cream

ABSORBINE JR by

Drug Labeling and Warnings

ABSORBINE JR by is a Otc medication manufactured, distributed, or labeled by Clarion Brands, LLC, DHALIWAL LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 2.5%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

• arthritis
• simple backache
• sprains
• strains
• bruises

Warnings

For external use only. 

Do not use

• on wounds or damaged skin

When using this product

• do not bandage tightly
• avoid contact with eyes and mucous membranes

Stop use and ask a doctor if

• condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 2 years of age and older: apply to the affected area no more than 3 to 4 times daily
• Children under 2 years of age; consult a doctor

Inactive ingredients

camphor, carbomer, cocoa butter, disodium EDTA, DMDM hydantoin, isopulegol, laureth-4, menthoxypropanediol, methyl salicylate, polysorbate-20, propylene glycol, shea butter, sodium hydroxide, vanillyl butyl ether, water, wormwood oil

Questions? Call 1-844-922-7672

PRINCIPAL DISPLAY PANEL

Fast-Acting & Strong

ABSORBINE jr.®

Pain Relieving Cream

Rapid Relief + Skin Moisturizers

Relieves:
Sore Muscles
Arthritis Pain

Net Wt 2 OZ (56.7 g)

Fast, effective relief from;
Sore Muscles
Arthritis Pain
Aching Joints & Stiffness
Backache
Foot Pain & Discomfort

Moisturizes Skin with Shea Butter & Cocoa Butter

Deep penetrating pain relief for use with chronic and activity-induced pain

Distributed by: Clarion Brands, LLC
27070 Miles Rd., Suite A, Solon, OH 44139
315521A   ©2015    www.absorbinejr.com

Fast-Acting & Strong

ABSORBINE jr. ®

Pain Relieving Cream

Rapid Relief + Skin Moisturizers

Relieves:
Sore Muscles
Arthritis Pain

Net Wt 2 OZ (56.7 g)

323853A

Uses: For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains, strains and bruises.

Directions: Apply to the affected area no more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Warnings: For external use only. Use only as directed. Keep out of reach of children. Avoid contact with eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again, discontinued use of this product and consult a doctor. Do not apply to wounds or damaged skin.

Active Ingredient: Menthol 2.5%

Inactive Ingredients: camphor, carbomer, cocoa butter, disodium EDTA, DMDM hydantoin, isopulegol, laureth-4, menthoxypropanediol, methyl salicylate, polysorbate-20, propylene glycol, shea butter, sodium hydroxide, vanillyl butyl ether, water, wormwood oil

Fast, effective relief from;
Sore Muscles
Arthritis Pain
Aching Joints & Stiffness
Backache
Foot Pain & Discomfort

Skin Moisturizers
Shea Butter
Cocoa Butter

Distributed by:
Clarion Brands, LLC
27070 Miles Rd., Suite A
Solon, OH 44139
1-844-922-7672
323854A    ©2015
www.absorbinejr.com

Label Patent #6,752,431

INGREDIENTS AND APPEARANCE

ABSORBINE JR 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69693-410
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ISOPULEGOL (UNII: 3TH92O3BXN)
LAURETH-4 (UNII: 6HQ855798J)
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)
WATER (UNII: 059QF0KO0R)
WORMWOOD OIL (UNII: 01756N87N8)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69693-410-02	1 in 1 CARTON	08/15/2015
1		56.7 g in 1 BOTTLE; 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	08/15/2015

Labeler - Clarion Brands, LLC (079742703)

Establishment
Name	Address	ID/FEI	Business Operations
DHALIWAL LABORATORIES, LLC		016754201	manufacture(69693-410)