REAL TIME PAIN RELIEF FOOT CREAM TOPICAL ANALGESIC- menthol 1.5% cream

Real Time Pain Relief Foot Cream by

Drug Labeling and Warnings

Real Time Pain Relief Foot 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 1.5%

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

• muscle strains
• sprains
• bruises
• cramps

WARNINGS

for external use only

When using this product

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

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

INACTIVE INGREDIENTS

Allantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL and DRUG FACTS

INGREDIENTS AND APPEARANCE

REAL TIME PAIN RELIEF FOOT CREAM  TOPICAL ANALGESIC
menthol 1.5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-900
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
ALPHA-TOCOPHERYLOXYACETIC ACID (UNII: JW7FJR3ZLY)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
LACTIC ACID (UNII: 33X04XA5AT)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
LANOLIN (UNII: 7EV65EAW6H)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
CETYL ALCOHOL (UNII: 936JST6JCN)
CORIANDER OIL (UNII: 7626GC95E5)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EMU OIL (UNII: 344821WD61)
WATER (UNII: 059QF0KO0R)
SALIX ALBA BARK (UNII: 205MXS71H7)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
HYDROGENATED COTTONSEED OIL (UNII: Z82Y2C65EA)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
RETINYL PROPIONATE (UNII: 32JK994WMC)
.ALPHA.-ISOBUTYLPHENETHYL ALCOHOL (UNII: 2SBL0E1I0N)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-900-04	125 g in 1 JAR; Type 0: Not a Combination Product	01/31/2014
2	NDC: 58133-900-14	40 g in 1 JAR; Type 0: Not a Combination Product	01/31/2014
3	NDC: 58133-900-08	227 g in 1 JAR; Type 0: Not a Combination Product	01/31/2014
4	NDC: 58133-900-16	453 g in 1 JAR; 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(58133-900)