Pain Relieving Roll-On: Package Insert and Label Information

PAIN RELIEVING ROLL-ON- menthol, unspecified form 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.

Drug Facts

Active Ingredients

USP Menthol 7%


Topical Analgesic


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


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.


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

Eucalyptus Oil, Glycerin, Isopropyl Alcohol, Methyl Salicylate, Purified Water, Tea Tree Oil, Xanthan Gum.

Principal Display Panel — 3 oz. Bottle Label





with Tea Tree & Eucalyptus Oils

Reorder No. 58003

3 fl. oz. (88ml) • Topical Analgesic

Principal Display Panel -- 3 oz. Bottle Label
(click image for full-size original)
menthol, unspecified form gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-1550
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
menthol, unspecified form (menthol, unspecified form) menthol, unspecified form 7 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
eucalyptus oil
Isopropyl Alcohol
methyl salicylate
Tea Tree Oil
Xanthan Gum
# Item Code Package Description Multilevel Packaging
1 NDC:61010-1550-1 88 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/07/2019
Labeler — Safetec of America, Inc. (874965262)
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE (61010-1550)

Revised: 10/2019 Safetec of America, Inc. provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

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