Helix

Manufacturer
Parker Laboratories, Inc.
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:45:03

Label at a glance#

ProductHelix
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure6 sections

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract,
Arnica Montana Flower Extract, Camphor, Carbomer,
Citrus Reticulata (Tangerine) Oil, Ethylhexylglycerin,
Fragrance, Ilex Paraguerensis Leaf Extract, Isopropyl
Alcohol, Lauryl PEG/PPG-18/18 Methicone, PEG-40
Hydrogenated Castor Oil, Phenoxyethanol, Propylene
Glycol, Sodium Hydroxide, Water

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.4%

Warnings

WARNINGS SECTION

Warnings For external use only.

When using this product Avoid contact with eyes
or mucous membranes ■ Do not apply to wounds or
damaged skin ■ Do not bandage tightly ■ Wash hands
with cool water after use ■ Do not use with heating
pad or device ■ Stop use and ask a doctor if you
experience signs of skin injury, such as pain, swelling,
or blistering where the product was applied.

Primary Package (Packet) Label including Drug Facts Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packet LabelPacket LabelDrug Facts

Active Ingredient Purpose

Menthol 7.4% ................................................................... Topical Analgesic

Uses For the temporary relief of minor aches and pains of

muscles and joints associated with: ■ simple

backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings For external use only.

When using this product Avoid contact with eyes

or mucous membranes ■ Do not apply to wounds or

damaged skin ■ Do not bandage tightly ■ Wash hands

with cool water after use ■ Do not use with heating

pad or device ■ Stop use and ask a doctor if you

experience signs of skin injury, such as pain, swelling,

or blistering where the product was applied.

Discontinue use and consult doctor if ■ condition

worsens, or if symptoms persist for more than 7 days

or clear up and recur

Flammable: Keep away from fire or flame

If pregnant or breastfeeding, ask a health

professional before use

Keep out of reach of children. If swallowed,

get medical help or contact a Poison Control Center

right away

Directions

Adults and children 2 years of age and older:

■ Rub a thin film over affected areas not more than 4

times daily ■ Wash hands after each use with cool water

Children under 2 years of age: Consult a physician

Inactive Ingredients Aloe Barbadensis Leaf Extract,

Arnica Montana Flower Extract, Camphor, Carbomer,

Citrus Reticulata (Tangerine) Oil, Ethylhexylglycerin,

Fragrance, Ilex Paraguerensis Leaf Extract, Isopropyl

Alcohol, Lauryl PEG/PPG-18/18 Methicone, PEG-40

Hydrogenated Castor Oil, Phenoxyethanol, Propylene

Glycol, Sodium Hydroxide, Water

©2018 Parker Laboratories, Inc.

286 Eldridge Road, Fairfield, NJ 07004 U.S.A.

Questions (Toll Free) 800-631-8888

helix4pain.com

CM-034-0001A

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30775-051-012020-11-02C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-032020-11-02C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-042020-11-02C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-122020-11-02C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-322020-11-02C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-502020-11-02C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-012020-09-27C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-032020-09-27C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-042020-09-27C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-122020-09-27C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-322020-09-27C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-502020-09-27C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-012020-09-25C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-032020-09-25C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-042020-09-25C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-122020-09-25C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-322020-09-25C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-502020-09-25C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-012020-07-22C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-032020-07-22C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-042020-07-22C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-122020-07-22C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-322020-07-22C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet
30775-051-502020-07-22C16284748780-1ab0e2407-28d5-f274-e053-dbdaa90a6471Helix 5g Packet

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30775-05130775-051-01, 30775-051-03, 30775-051-04, 30775-051-12, 30775-051-32, 30775-051-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
05a47dd2-4c85-4a81-e063-6394a90a9bbc73557911-4005-6e66-e053-2a91aa0ac6202023-09-18WarningsExact identifier
spl set id: 73557911-4005-6e66-e053-2a91aa0ac620

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.