ICE- 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 Ingredient

Menthol 3.5%

Purpose

Pain Reliever

Uses

Temporarily relieves minor pain associated with: muscle sprains, muscle strains, neck/back aches/pains, sore joints, arthritis, cramps and bruises.

Warnings

For external use only. Flammable. Keep away from open flame or extreme heat.

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

When using this product: Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Do not use with a heating pad or other ointments, creams, sprays or liniments. Do not apply to irritated skin. Wash hands thoroughly after each application.

Stop use and ask a health professional if condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, or if irritation occurs.

If pregnant or breast feeding ask a health care professional before use. Store at room temperature.

Directions

For adults and children 6 years of age and older: Clean skin. Apply a liberal amount of gel directly on the skin over the affected area until absorbed into skin. Repeat as necessary, but not more than 4 times daily. May also be applied before or after activity. For children under 6 years of age, consult a health care professional.

Inactive ingredients

Aloe Barbadensis SDA 38B, Glycerin, Xanthan Gum, Mentha Piperita (Peppermint) Oil, Dehydroxyxanthan Gum, Cinnamomum Camphora (Camphor) Bark Oil, Organic Chamomilla Recutita (Matricaria) Flower Extract, Organic Symphytum Officinalis (Comfrey)

Principal Display Panel - Carton Label

Safetec

ICE

Pain Relieving
Muscle Rub

Calms arthritis
Eases back aches
Relieves joint sprains

mild mint gel

100 Packets, 4 mL Each

Principal Display Panel - Bottle Label

Safetec

ICE

Pain Relieving
Muscle Rub

Calms arthritis
Eases back aches
Relieves joint sprains

mild mint gel

Net 16 fluid oz. / 473 mL

ICE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61010-1250
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
menthol (UNII: L7T10EIP3A) (menthol - UNII:L7T10EIP3A)	menthol	34.79 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
aloe vera leaf (UNII: ZY81Z83H0X)
glycerin (UNII: PDC6A3C0OX)
peppermint oil (UNII: AV092KU4JH)
xanthan gum (UNII: TTV12P4NEE)
camphor oil (UNII: 75IZZ8Y727)
matricaria recutita (UNII: G0R4UBI2ZZ)
symphytum uplandicum leaf (UNII: D05HXK6R3G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61010-1250-3	100 in 1 CARTON	08/18/2014	11/26/2014
1	NDC:61010-1250-1	4 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC:61010-1250-2	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2014	11/26/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/18/2014	11/26/2014

Labeler - Safetec of America, Inc (874965262)

Revised: 12/2019

Document Id: 587758ca-e3ab-44b3-bcce-8f45ca3f5133

Set id: b6f08e1d-08bd-43cd-ae31-0c1c7491f146

Version: 4

Effective Time: 20191209

Safetec of America, Inc