Your browser does not support JavaScript! REZIL (CAPSAICIN) LOTION [TOQARA, INC.]
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REZIL (capsaicin) lotion
[Toqara, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENTS SECTION

DRUG FACTS

CAPSAICIN 0.025%

PURPOSE SECTION

TOPICAL ANALGESIC

KEEP OUT OF REACH OF CHILDREN SECTION

KEEP AWAY FROM CHILDREN.

INDICATIONS AND USES SECTION

USES: FOR TEMPORARY RELIEF OF MINOR ACHES, AND PAINS OF MUSCLES AND JOINTS ASSOCIATED WITH ARTHRITIS, STRAINS, SPRAINS, AND BRUISES.

WARNINGS SECTION

WARNINGS: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. IF CONDITION WORSEN, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE A CONSULT A PHYSICIAN. DO NOT APPLY TO WOUNDS OR DAMAGED SKIN. DO NOT BANDAGE TIGHTLY.

DOSAGE AND ADMINISTRATION SECTION

DIRECTIONS: ADULTS AND CHILDREN OVER 6 YEARS OF AGE - APPLY TO AFFECTED AREA AND RUB GENTLY UNTIL ABSORBED. DO NOT USE MORE THAN 3 OR 4 TIMES DAILY.

INACTIVE INGREDIENTS SECTION

ISOHEXADECANE, MINERAL OIL AND DIMETHICONE

QUESTIONS OR COMMENTS SECTION

QUESTIONS OR COMMENTS? 1-800-000-0000 OR GO TO WWW.TOQARA.COM

OTHER INFORMATION SECTION

OTHER INFORMATION: STORE AT ROOM TEMPERATURE

PACKAGE LABEL SECTION

REZIL PAIN RELIEF LOTION ROLL-ON

PENETRATING PAIN RELIEF FOR ARTHRITIS, STRAINS, SPRAINS AND BRUISES

NET 3 FLUID OZ./88ML  MANUFACTURED FOR TOQARA, INC. LAKEWOOD, CO 80214


REZIL LABEL











REZIL PAIN RELIEF LOTION ROLL-ON  PENETRATING PAIN RELIEF FOR ARTHRITIS, STRAINS, SPRAINS AND BRUISES
HANDY POCKET/PURSE SIZE ROLL-ON  READ BACK OF CARD FOR FULL DETAILS  RETAIN INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS 
NET 1/4 FLUID OX./7.4 ML.
MANUFACTURED FOR:TOQARA, INC. LAKEWOOD, CO 80214 USA, 303-205-9032  WWW.REZIL.COM


REZIL PRODUCT LABEL


REZIL FRONT LABEL

REZIL BACK LABEL

REZIL 
capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76468-121
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.025 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISOHEXADECANE 
MINERAL OIL 
DIMETHICONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76468-121-0488 mL in 1 BOTTLE, WITH APPLICATOR
2NDC:76468-121-017.4 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2011
Labeler - Toqara, Inc. (034921977)
Registrant - Toqara, Inc. (034921977)

Revised: 9/2011
 
Toqara, Inc.

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