PAIN RELIEVER- menthol gel

PAIN RELIEVER by

Drug Labeling and Warnings

PAIN RELIEVER by is a Otc medication manufactured, distributed, or labeled by CA-BOTANA INTERNATIONAL, RODOLFO UGELSTAD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Warnings:

For external use only.
Do not use on wounds or damaged skin
When using this product: use only as directed. Avoid contact with eyes. Do no bandage tightly
Stop use and ask a doctor if: redness is present. Irritation develops. Condition worsens or symptoms persist more than 7 days. Symptoms clear up and occur again within a few days.
Store at room temperature. Lot number and expiration date see crimp or see box.

DOSAGE & ADMINISTRATION

Directions:

Adults and children over 12 year. Apply generous amount directly to affected area. Massage into painful area until thoroughly absorbed into skin. Repeat as necessary, but no more that 4 times daily.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
Water. Ethanol. PPG-26 Buteth-26 (and) PEG-40. Hydrogenated Castor Oil. Acrylates/C10-30 alkyl acrylate crosspolymer. Triethanolamine. Glucosamine Sulfate. Methyl Sulfonyl Methane. (MSM). Bromelain. Harpagophytum procumbens (Devil's Claw). Hippocastanaceae aesculus hippocastanum (Horse Chestnut). Rosmarinus officinalis. Aloe barbadenis miller. Chamaemelum nobile. Capsicum annuun Extract. Tilia cordata Extract (Linden flower). Melissa officinalis. Arnica montana. Saliz alba. Eucalyptus globoulus. Tocopheryl acetate. Phenoxyethanol Ethylhexyglycerin. Potassium Sorbate. EDTA. FD and C Green # 3. FD and C Yellow # 10

PURPOSE

Uses for temporary relief of minor aches and pains of muscles and joint associated with: simple aches, back aches, arthritis, strains, bruises, sprains.

ACTIVE INGREDIENT

Menthol 2% Topical analgesic

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.

INDICATIONS & USAGE

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN RELIEVER 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35192-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.4 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHANOL (UNII: 3K9958V90M)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
TROLAMINE (UNII: 9O3K93S3TK)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
BROMELAINS (UNII: U182GP2CF3)
HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
ALOE FEROX LEAF (UNII: 0D145J8EME)
CHAMAEMELUM NOBILE (UNII: 7NF3GE7IWR)
CAPSICUM (UNII: 00UK7646FG)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
MELISSA OFFICINALIS (UNII: YF70189L0N)
ARNICA MONTANA (UNII: O80TY208ZW)
SALIX ALBA LEAF (UNII: M7S08QZ9JA)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETIC ACID (UNII: 9G34HU7RV0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35192-002-02	120 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/24/2011

Labeler - CA-BOTANA INTERNATIONAL (106276728)

Registrant - RODOLFO UGELSTAD (106276728)

Establishment
Name	Address	ID/FEI	Business Operations
CA-BOTANA INTERNATIONAL		106276728	manufacture