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%

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

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

Principal Display Panel — 3 oz. Bottle Label

Safetec

PAIN RELIEVING

ROLL-ON

FAST-ACTING MUSCLE RELIEF

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)
PAIN RELIEVING ROLL-ON
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
glycerin
Isopropyl Alcohol
methyl salicylate
water
Tea Tree Oil
Xanthan Gum
Packaging
# 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)
Establishment
Name Address ID/FEI Operations
Safetec of America, Inc. 874965262 MANUFACTURE (61010-1550)

Revised: 10/2019 Safetec of America, Inc.

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