OTC Medication Information: PAIN RELIEVER

PAIN RELIEVER — menthol gel
CA-BOTANA INTERNATIONAL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.
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 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

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

Menthol 2% Topical analgesic

Keep out of reach of children. If swallowed get medical help or contact a Posion Control Center immediately.
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PAIN RELIEVER
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35192-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 2.4 g in 120 g
Inactive Ingredients
Ingredient Name Strength
WATER
ETHANOL
HYDROGENATED CASTOR OIL
CARBOMER COPOLYMER TYPE A
TROLAMINE
GLUCOSAMINE SULFATE
DIMETHYL SULFONE
BROMELAINS
HARPAGOPHYTUM PROCUMBENS ROOT
HORSE CHESTNUT
ROSMARINUS OFFICINALIS FLOWER
ALOE FEROX LEAF
CHAMAEMELUM NOBILE
CAPSICUM
TILIA CORDATA FLOWER
MELISSA OFFICINALIS
ARNICA MONTANA
SALIX ALBA LEAF
EUCALYPTUS GLOBULUS LEAF
.ALPHA.-TOCOPHEROL ACETATE, D-
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
POTASSIUM SORBATE
EDETIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35192-002-02 120 g in 1 TUBE None
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 Operations
CA-BOTANA INTERNATIONAL 106276728 manufacture

Revised: 08/2011 CA-BOTANA INTERNATIONAL

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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