r3

r3
SPL v1
SPL
SPL Set ID d60aa227-eb1c-46ad-bb60-3a37165b8083
Route
topical
Published
Effective Date 2022-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.75 g)
Inactive Ingredients
emu oil carbomer homopolymer, unspecified type cannabis sativa seed oil ppg-20 methyl glucose ether isopropyl alcohol oleth-10 peg-75 lanolin water sodium thiosulfate iodine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2022-11-09

Purpose

Topical Analgesic

Description

Menthol 2.75%


Medication Information

Warnings

For external use only

When using this product • use only as directed • do not bandage tightly or use with heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation or redness may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable • keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before use.

Uses

temporarily relieves minor pain associated with:

• arthritis • simple backache • muscle strains • sprains • bruises • cramps

Purpose

Topical Analgesic

Directions

For Adults and Children over 12         SHAKE WELL BEFORE EACH USE

• apply generously to affected area • massage into painful area until completely absorbed • You may apply 4 to 6 times a day or as needed

Children under 12 years - ask your doctor.

Inactive Ingredients

Emu Oil, Carbomer, Organic Hemp (Cannabis Sativa Seed) Oil, PPG-20 Methyl Glucose Ether, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate, Tincture of Iodine.

Description

Menthol 2.75%

Section 42229-5

Sport Pain Relief Hemp Roll-On

1500mg Hemp Oil

Temporary relief of minor pain associated with ARTHRITIS, MUSCULAR ACHES, STRAINS, SORENESS AND BACKACHE

MADE IN USA

Manufactured For:

Revive 1, LLC

Incline Village, NV 89451

www.revive1.net 877-577-2289

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient:

Menthol 2.75%


Structured Label Content

Warnings

For external use only

When using this product • use only as directed • do not bandage tightly or use with heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation or redness may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable • keep away from fire or flame

If pregnant or breast-feeding, ask a health professional before use.

Uses

temporarily relieves minor pain associated with:

• arthritis • simple backache • muscle strains • sprains • bruises • cramps

Purpose

Topical Analgesic

Directions

For Adults and Children over 12         SHAKE WELL BEFORE EACH USE

• apply generously to affected area • massage into painful area until completely absorbed • You may apply 4 to 6 times a day or as needed

Children under 12 years - ask your doctor.

Inactive Ingredients

Emu Oil, Carbomer, Organic Hemp (Cannabis Sativa Seed) Oil, PPG-20 Methyl Glucose Ether, Isopropyl Alcohol USP, Oleth-10, PEG-75 Lanolin, Purified Water, Sodium Thiosulfate Pentahydrate, Tincture of Iodine.

Section 42229-5 (42229-5)

Sport Pain Relief Hemp Roll-On

1500mg Hemp Oil

Temporary relief of minor pain associated with ARTHRITIS, MUSCULAR ACHES, STRAINS, SORENESS AND BACKACHE

MADE IN USA

Manufactured For:

Revive 1, LLC

Incline Village, NV 89451

www.revive1.net 877-577-2289

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Drug Facts

Active Ingredient:

Menthol 2.75%


Advanced Ingredient Data


Raw Label Data

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