pain crush

pain crush
SPL v2
SPL
SPL Set ID 6e8dd8bb-7204-34ca-e053-2a91aa0a9ef3
Route
topical
Published
Effective Date 2019-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (7 g)
Inactive Ingredients
aloe vera leaf water glycerin xanthan gum alcohol licorice peppermint

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-06-13

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Active Ingredient

Active ingredient +

Menthol 7%

Indications and Usage

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration

Directions

  • shake well before each use
  • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store between 20 to 25°C (68 to 77°F)
  • close cap tightly after use
  • see bottom of bottle for Lot No. and Exp. Date.
Section 50565-1

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

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
  • excessive skin irritation occurs
Section 50567-7

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or use with a heating pad
Section 50569-3

Ask a doctor before use if you have redness over the affected area.

Section 50570-1

Do not use

  • on wounds or damaged skin
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6

Inactive ingredients

organic aloe vera leaf juice, organic ethyl alcohol, organic glycerin, organic licorice root extract, organic peppermint oil, purified water (aqua), xanthan gum

Section 51945-4

Genexa®

COLD THERAPY PAIN RELIEF ROLL ON

PAIN CRUSH™

Menthol / Topical Analgesic

3 FL OZ (89 mL)

Back Pain + Arthritis / Sore Muscles + Joints / Shoulder + Leg Pain

USDA ORGANIC

NON GMO Project VERIFIED

FREE OF DYES & PARABENS

NDC 69676-0004-6

Section 53414-9

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

Section 55105-1

Purpose

Topical analgesic


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Active Ingredient (55106-9)

Active ingredient +

Menthol 7%

Indications and Usage (34067-9)

Uses temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Dosage and Administration (34068-7)

Directions

  • shake well before each use
  • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store between 20 to 25°C (68 to 77°F)
  • close cap tightly after use
  • see bottom of bottle for Lot No. and Exp. Date.
Section 50565-1 (50565-1)

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

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
  • excessive skin irritation occurs
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly or use with a heating pad
Section 50569-3 (50569-3)

Ask a doctor before use if you have redness over the affected area.

Section 50570-1 (50570-1)

Do not use

  • on wounds or damaged skin
  • on a child under 12 years of age with arthritis-like conditions
Section 51727-6 (51727-6)

Inactive ingredients

organic aloe vera leaf juice, organic ethyl alcohol, organic glycerin, organic licorice root extract, organic peppermint oil, purified water (aqua), xanthan gum

Section 51945-4 (51945-4)

Genexa®

COLD THERAPY PAIN RELIEF ROLL ON

PAIN CRUSH™

Menthol / Topical Analgesic

3 FL OZ (89 mL)

Back Pain + Arthritis / Sore Muscles + Joints / Shoulder + Leg Pain

USDA ORGANIC

NON GMO Project VERIFIED

FREE OF DYES & PARABENS

NDC 69676-0004-6

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Topical analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)