Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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LUCKY SUPERSOFT MUSCLE AND JOINT- camphor menthol methyl salicylate cream 
Delta Brands 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.

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Drug Facts

Active ingredients

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

Topical analgesic

Topical analgesic

Topical analgesic

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

For external use only

Do not use

■ on wounds or damaged skin ■ with a heating pad

■ on a child under 12 years of age with arthritis like conditions

When using this product

■ avoid contact with eyes or mucous membranes ■ do not bandage tightly

Stop use and ask a doctor if

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

■ excessive skin irritation occurs

Keep out of reach of children

to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

■ use only as directed ■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 time daily

■ children under 12 years of age: ask a doctor

Other information

■ store between 20 to 25C (68 to 77F) ■ do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

Inactive ingredients

carbomer 940, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Package Label

image description

LUCKY SUPERSOFT  MUSCLE AND JOINT
camphor menthol methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 20276-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
LANOLIN (UNII: 7EV65EAW6H)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 20276-106-4242.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/31/2015
Labeler - Delta Brands Inc (102672008)
Establishment
NameAddressID/FEIBusiness Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(20276-106)

Revised: 2/2015
 
Delta Brands Inc


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