REAL TIME PAIN RELIEF SPORTS CREAM TOPICAL ANALGESIC- menthol 0.5% lotion

Real Time Pain Relief Sports Cream by

Drug Labeling and Warnings

Real Time Pain Relief Sports Cream by is a Otc medication manufactured, distributed, or labeled by Cosmetic Specialty labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 0.5%

PURPOSE

Topical analgesic

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

USES

Temporarily relieves minor pain associated with

• arthritis
• simple backache
• muscle strains
• sprains
• bruises

WARNINGS

for external use only

When using this product

• use only as directed
• avoid contact with eyes or mucus membranes
• do not apply to wounds or damaged skin
• do not bandage tightly

Stop using and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops

If pregnant or breast-feeding

ask a health professional before use

DIRECTIONS

adults and children over 2 years

• apply generously to affected area
• massage into painful area until throughly absorbed into skin
• repeat as necessary, but no more than 4 times daily

children 2 years or younger: ask a doctor

children 12 years or younger

ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REAL TIME PAIN RELIEF SPORTS CREAM  TOPICAL ANALGESIC
menthol 0.5% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CARBOMER 934 (UNII: Z135WT9208)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CORIANDER OIL (UNII: 7626GC95E5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
EMU OIL (UNII: 344821WD61)
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
WATER (UNII: 059QF0KO0R)
SALIX ALBA BARK (UNII: 205MXS71H7)
SORBITOL (UNII: 506T60A25R)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
MYRISTICA FRAGRANS WHOLE (UNII: MF7T8BM40A)
TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATE (UNII: E6DVO371LC)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
2-(DIPROPYLAMINO)ETHANOL (UNII: 0916206V9S)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ORIGANUM MAJORANA (UNII: R40XM3HU5X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)
CUPRESSUS SEMPERVIRENS LEAF OIL (UNII: M7QUY89S4O)
GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-700-04	120 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/31/2014
2	NDC: 58133-700-12	345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/31/2014
3	NDC: 58133-700-40	120 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2014
4	NDC: 58133-700-15	45 mL in 1 TUBE; Type 0: Not a Combination Product	01/31/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/30/2013

Labeler - Cosmetic Specialty labs, Inc. (032973000)

Registrant - Cosmetic Specialty labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty labs, Inc.		032973000	manufacture(58133-700)