Hempvana Cold As Ice Gel

Hempvana Cold As Ice Gel
SPL v2
SPL
SPL Set ID a9e103f2-778f-e49b-e053-2a95a90aa8b7
Route
TOPICAL
Published
Effective Date 2020-07-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (8 mg)
Inactive Ingredients
Isopropyl Myristate Sodium Hydroxide Water Camphor, (-)- Turmeric Carbomer Homopolymer, Unspecified Type Alpha-tocopherol Acetate Green Tea Leaf Melissa Officinalis Flowering Top Edetic Acid Fd&c Blue No. 1 Alcohol Silica Dimethyl Silylate Ilex Paraguariensis Leaf Phenoxyethanol Ethylhexylglycerin Fd&c Yellow No. 5 Glycerin Cannabis Sativa Seed Oil Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Calendula Officinalis Flowering Top

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-07

Description

Menthol USP 8% w/w

Purpose

Menthol USP 8% w/w................Topical Analgesic


Medication Information

Warnings and Precautions

For external use only

Flammable: Keep away from excessive heat or open flame

Purpose

Menthol USP 8% w/w................Topical Analgesic

Description

Call (855) 877-4503 (M-F, 9am-5pm EST)

Does not contain NSAIDS, ibuprofen, Aspirin or Salicylate

For more information visit www.hempvana.com

Dist. By: Telebrands Corp.

79 Two Bridges Road

Fairfield, NJ 07004

Uses

temporarily relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7

When using this product, avoid contact with eyes.

  • Do not apply to wounds or damaged skin
  • Do nut use in large quantities, particularly over raw surfaces or blistered areas.
  • Do not bandage tightly
Section 51945-4

Cold Therapy For Pain

Hempvana

#1 Hemp Brand in America

Cold as Ice Pain Relief Gel

Enriched with hemp seed oil turmeric and aloe

Menthol USP 8%

For arthritis, back, shoulder, joint & muscle pain

phthalate free - paraben free - vegan - gluten free - cruelty free

4 fl oz (118 mL)

As seen on TV

Section 53414-9

If pregnant or nursing,ask a healthcare professional before using.

Directions

Adults:Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water.

For children under 18 years of age: Consult a physician.

Active Ingredient

Menthol USP 8% w/w

Other Information

Store tightly closed in a cool dry place.

Inactive Ingredients

water/aqua/eau, alcohol denat., isopropyl myristate, sodium hydroxide, silica silylate, hemp seed oil, camphor, aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, curcuma longa (turmeric) root extract, ilex paraguariensis leaf extract, melissa officinalis flower/leaf/stem extract, phenoxyethanol, carbomer, ethylhexylglycerin, disodium edta, tocopheryl acetate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).


Structured Label Content

Uses

temporarily relief of minor aches and pains of muscles and joints associated with:

• simple backache • arthritis • strains • bruises • sprains

Warnings and Precautions (34071-1)

For external use only

Flammable: Keep away from excessive heat or open flame

Description (34089-3)

Call (855) 877-4503 (M-F, 9am-5pm EST)

Does not contain NSAIDS, ibuprofen, Aspirin or Salicylate

For more information visit www.hempvana.com

Dist. By: Telebrands Corp.

79 Two Bridges Road

Fairfield, NJ 07004

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
Section 50567-7 (50567-7)

When using this product, avoid contact with eyes.

  • Do not apply to wounds or damaged skin
  • Do nut use in large quantities, particularly over raw surfaces or blistered areas.
  • Do not bandage tightly
Section 51945-4 (51945-4)

Cold Therapy For Pain

Hempvana

#1 Hemp Brand in America

Cold as Ice Pain Relief Gel

Enriched with hemp seed oil turmeric and aloe

Menthol USP 8%

For arthritis, back, shoulder, joint & muscle pain

phthalate free - paraben free - vegan - gluten free - cruelty free

4 fl oz (118 mL)

As seen on TV

Section 53414-9 (53414-9)

If pregnant or nursing,ask a healthcare professional before using.

Purpose

Menthol USP 8% w/w................Topical Analgesic

Directions

Adults:Apply to affected are not more than 3 to 4 times daily. If product comes in contact with hands, wash with soap and water.

For children under 18 years of age: Consult a physician.

Active Ingredient

Menthol USP 8% w/w

Other Information

Store tightly closed in a cool dry place.

Inactive Ingredients

water/aqua/eau, alcohol denat., isopropyl myristate, sodium hydroxide, silica silylate, hemp seed oil, camphor, aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, calendula officinalis flower extract, camellia sinensis leaf extract, curcuma longa (turmeric) root extract, ilex paraguariensis leaf extract, melissa officinalis flower/leaf/stem extract, phenoxyethanol, carbomer, ethylhexylglycerin, disodium edta, tocopheryl acetate, Yellow 5 (Cl 19140), Blue 1 (Cl 42090).


Advanced Ingredient Data


Raw Label Data

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