Analgesic by Safetec of America, Inc. / Safetec of America, Inc ANALGESIC- menthol gel

Analgesic by

Drug Labeling and Warnings

Analgesic by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Inc., Safetec of America, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANALGESIC 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61010-8202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	70 mg  in 1 L

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61010-8202-0	0.088 L in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2018

Labeler - Safetec of America, Inc. (874965262)

Establishment
Name	Address	ID/FEI	Business Operations
Safetec of America, Inc		874965262	MANUFACTURE(61010-8202)