SPL v1
SPL
SPL Set ID 5e6f3eac-377d-43e6-83bc-e7e972db1e83
Route
TOPICAL
Published
Effective Date 2014-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3.5 mg)
Inactive Ingredients
Aloe Vera Leaf Glycerin Peppermint Oil Xanthan Gum Camphor Oil Matricaria Recutita Symphytum Uplandicum Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-18

Description

Drug Facts

Purpose

Pain Reliever


Medication Information

Purpose

Pain Reliever

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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: Shake well. 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.

Active Ingredient

Menthol 3.5%

Inactive Ingredients

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

Rescue Health, LLC

Bentonville, AR 72712

www.rawhealthintl.com

Ph: 1-888-RAW-HLTH

Questions Or Comments:

Email us at: [email protected]

Principal Display Panel Bottle Label

RAW™

ICE

100% Natural

Pain Relief

For arthritis, muscle

and joint pain

ROLL-ON GEL

3 fl OZ/89 mL


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Pain Reliever

Directions

For adults and children 6 years of age and older: Shake well. 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.

Active Ingredient

Menthol 3.5%

Inactive Ingredients

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

Rescue Health, LLC

Bentonville, AR 72712

www.rawhealthintl.com

Ph: 1-888-RAW-HLTH

Questions Or Comments: (Questions or comments:)

Email us at: [email protected]

Principal Display Panel Bottle Label (Principal Display Panel - Bottle Label)

RAW™

ICE

100% Natural

Pain Relief

For arthritis, muscle

and joint pain

ROLL-ON GEL

3 fl OZ/89 mL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)