ANALGESIC- menthol gel 
Safetec of America, Inc.

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.

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Drug Facts

Active Ingredients

USP Menthol 7%

Purpose

Topical Analgesic

Uses

Temporary relief of minor aches and pains of muscles and joints.

Warnings

For external use only.

Flammable.

Keep away from flame.

Keep out of reach of children.

If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

Store at room temperature.

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum.

Principal Display Panel - Pain Relief Roll-On Bottle Label

NDC 61010-XXXX-X

Safetec

PAIN
RELIEF
ROLL-ON

MEDICATED FAST-ACTING

For temporary relief of
minor aches and pains

3 fl. oz. (88 ml)

Reorder no. 58001

Principal Display Panel - Pain Relief Roll-On Bottle Label
ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-8202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A) menthol70 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
isopropyl alcohol (UNII: ND2M416302)  
glycerin (UNII: PDC6A3C0OX)  
eucalyptus oil (UNII: 2R04ONI662)  
methyl salicylate (UNII: LAV5U5022Y)  
peppermint oil (UNII: AV092KU4JH)  
coconut oil (UNII: Q9L0O73W7L)  
xanthan gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-8202-00.088 L in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2018
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc874965262MANUFACTURE(61010-8202)

Revised: 10/2018
Document Id: a4cdd5eb-fbda-4f99-b737-452a1487adfd
Set id: a90266d4-1e71-4805-aeca-6f8ed45135bb
Version: 1
Effective Time: 20181001
 
Safetec of America, Inc.