PAIN-EASE- camphor (natural) menthol methyl salicylate lotion 
VITALIFE INC DBA TABAKS HEALTH PRODUCTS

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.

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ACTIVE INGREDIENTS

METHYL SALICYLATE 28%
MENTHOL 8.8%
CAMPHOR 2.8%

PURPOSE

RELIEVES MINOR ACHES AND PAINS

STOP USE AND ASK A PHYSICIAN IF

  • SYMPTOMS PERSIST FOR MORE THAN 7 DAYS
  • SYMPTOMS CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS
  • CONDITION WORSENS

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES, MOUTH, GENITALIA AND BROKEN SKIN
  • DO NOT APPLY TO WOUNDS OR DAMAGED SKIN
  • DO NOT BANDAGE OR APPLY EXTERNAL HEAT TO AFFECTED AREA

DIRECTIONS

  • APPLY LOTION TO PAINFUL AREA
  • RUB INTO SKIN
  • REPEAT AS NEEDED

ADULTS AND CHILDREN 12 YEARS AND OLDER - USE AS DIRECTED

CHILDREN UNDER 12 - DO NOT USE

OTHER INFORMATION

  • KEEP CAP TIGHTLY CLOSED
  • STORE IN A COOL, DRY, DARK PLACE

ACTIVE INGREDIENTS

WATER, CARTHAMUS TINCTORIUS (SAFFLOWER) OIL, CETHYL ALCOHOL, STEARIC ACID, PEG-75 STEARATE, STEARETH-20, CETETH-20, POLOXAMER 407, GLYCERYL STEARATE, PEG-100 STEARATE, MAGNESIUM ALUMINUM SILICATE, LECITHIN, ISOPROPYL MYRISTATE, METHYLPARABEN, PROPYLPARABEN, SDA 40B, TRIETHANOLAMINE, DISODIUM EDTA, FRAGRANCE.

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

USES

TEMPORARILY RELIEVES

  • ARTHRITIS PAIN
  • INFLAMED JOINTS
  • BACKACHES
  • SORE MUSCLES

WARNINGS

For external use only.

Pain Ease Label

PAIN-EASE 
camphor (natural) menthol methyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61912-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL).028 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.088 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.28 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALCOHOL (UNII: 3K9958V90M)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CETETH-20 (UNII: I835H2IHHX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61912-001-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/201012/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/24/201012/15/2017
Labeler - VITALIFE INC DBA TABAKS HEALTH PRODUCTS (831564919)
Registrant - VITALIFE INC DBA TABAKS HEALTH PRODUCTS (831564919)

Revised: 12/2017
 
VITALIFE INC DBA TABAKS HEALTH PRODUCTS