Real Time Pain Relief Topical Analgesic

Dosage form: lotion
Ingredients: menthol 1g in 100mL
Labeler: Cosmetic Specialty labs, Inc.
NDC code: 58133-052

ACTIVE INGREDIENT

Menthol 1%

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
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 deveops

If pregnant or breast-feeding

ask a health professional before use

DIRECTIONS

adults and children over 12 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 12 years or younger

ask a doctor

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Blue 1, Calendula officinalis Extract, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Methylparaben, Methysulfonylmethane, Pimpinella Anisum (Anise) Fruit Extract, Propylparaben, Purified Water, Ruta Graveolens (Rue) Leaf/Root/Stem Extract. Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol. Tilia sylvestris Extract, Triethanolamine.

PRINCIPAL DISPLAY PANEL

REAL TIME PAIN RELIEF TOPICAL ANALGESIC
menthol 1% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58133-052
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (MENTHOL)	menthol	1 g in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
CHAMAEMELUM NOBILE FLOWER
ARNICA MONTANA FLOWER
FD&C BLUE NO. 1
CALENDULA OFFICINALIS FLOWER
CAPSICUM
CARBOMER 934
CENTAUREA CYANUS FLOWER
CETOSTEARYL ALCOHOL
CETYL ALCOHOL
CORIANDER OIL
DIAZOLIDINYL UREA
EMU OIL
GLUCOSAMINE HYDROCHLORIDE
HAMAMELIS VIRGINIANA TOP
METHYLPARABEN
DIMETHYL SULFONE
ANISE
PROPYLPARABEN
WATER
RUTA GRAVEOLENS FLOWERING TOP OIL
SALIX ALBA BARK
ISOPROPYL ALCOHOL
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)
SORBITOL
TILIA X EUROPAEA FLOWER
TROLAMINE

Packaging
#	Item Code	Package Description
1	NDC:58133-052-02	59 mL in 1 TUBE
2	NDC:58133-052-03	89 mL in 1 BOTTLE
3	NDC:58133-052-05	148 mL in 1 TUBE
4	NDC:58133-052-16	473 mL in 1 BOTTLE

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)

Establishment
Name	Address	ID/FEI	Operations
Cosmetic Specialty labs, Inc.		032973000	manufacture(58133-052)

Revised: 03/2013

Document Id: 3d4dd63b-b02e-464d-aa9e-6a0b3471aa26

Set id: 49922962-cf03-421b-ae91-9581a7daf81e

Version: 1

Effective Time: 20130327

Cosmetic Specialty labs, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Real Time Pain Relief Topical Analgesic

Further information

See also:

Mounjaro

Rybelsus

Zepbound

Wegovy

Victoza

Saxenda

Alli

Methamphetamine

Amphetamine

Tirzepatide