LUCKY SUPERSOFT MUSCLE AND JOINT- camphor menthol methyl salicylate cream

Lucky SuperSoft by

Drug Labeling and Warnings

Lucky SuperSoft by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc, Anicare Pharmaceuticals Pvt. ltd., ANICARE PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

LUCKY SUPERSOFT  MUSCLE AND JOINT
camphor menthol methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-106-42	42.5 g in 1 TUBE; Type 0: Not a Combination Product	01/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/31/2015

Labeler - Delta Brands Inc (102672008)

Establishment
Name	Address	ID/FEI	Business Operations
ANICARE PHARMACEUTICALS PRIVATE LIMITED		916837425	manufacture(20276-106)