ONEBACK- menthol gel
WORLD WIDE MEDICAL SERVICES, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ACTIVE INGREDIENTS

NATURAL MENTHOL 3.9%

PURPOSE

COOLING PAIN RELIEF

USES

TEMPORARY RELIEF OF

ARTHRITIS
BACKACHE
STRAINS
SPRAINS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE NEAR EYES, MOUTH, MUCUS MEMBRANES, CUTS, RASHES, AND SORES. IF CONTACT OCCURS, FLUSH WITH COLD WATER.

DO NOT USE WITH HEATING PAD OR DEVICE, OR UNDER BANDAGE.

DO NOT USE IF PREGNANT OR BREAST FEEDING. PLEASE CONSULT YOUR PHYSICIAN PRIOR TO USE.

DO NOT APPLY TO WOUNDS OR DAMAGED SKIN.

STOP USE AND ASK A DOCTOR IF IRRITATION PERSISTS.

KEEP OUT OF REACH OF CHILDREN. IF ACCIDENTALLY INGESTED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY
RUB IN THOROUGHLY UNTIL IT IS ABSORBED.

INACTIVE INGREDIENTS

WATER, ISOPROPYL ALCOHOL, PROPYLENE GLYCOL, GLYCERINE, CARBOMER, ILEX PARAGUARIENSIS LEAF EXTRACT, HYDRATED SILICA, AMINOMETHYL PROPANOL, METHYL PARABEN, UNCARIA TOMENTOSA EXTRACT, BOSWEILA SERRATA EXTRACT, CAMPHOR FOR SCENT

Label Cool Pain Relieving Gel 3oz. (2.13.2015)

ONEBACK
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69643-107
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.9 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
METHYLPARABEN (UNII: A2I8C7HI9T)
UNCARIA TOMENTOSA LEAF (UNII: 487U8M3D2P)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
CAMPHOR OIL (UNII: 75IZZ8Y727)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69643-107-16	88.8 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/03/2015	04/30/2015

Labeler - WORLD WIDE MEDICAL SERVICES, INC. (101816366)

Revised: 4/2015

Document Id: 9e7c82a9-3c56-4cd4-89d6-dec929d52e4e

Set id: 90fdf3ad-6d85-43e8-91e9-a748f2267b3e

Version: 2

Effective Time: 20150430

WORLD WIDE MEDICAL SERVICES, INC.