HELIX- pain relieving cream cream

Helix by

Drug Labeling and Warnings

Helix by is a Otc medication manufactured, distributed, or labeled by Parker Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Dosage and Administration from Drug Facts Label

Indications and Usage

Keep Out of Reach of Children

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

Purpose

Topical Analgesic

Active Ingredient

Menthol 7.4%

Warnings

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

Drug 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

INGREDIENTS AND APPEARANCE

HELIX 
pain relieving cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30775-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	7.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TANGERINE PEEL (UNII: JU3D414057)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
PENTADECALACTONE (UNII: OK17S3S98K)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30775-051-01	4 in 1 CASE	08/23/2018
1		100 in 1 BOX
1		5 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 30775-051-03	6 in 1 CASE	08/23/2018
2		12 in 1 BOX
2		85.06 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
3	NDC: 30775-051-04	6 in 1 CASE	08/23/2018
3		12 in 1 BOX
3		114.46 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 30775-051-12	4 in 1 CASE	08/23/2018
4		12 in 1 BOX
4		343.38 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
5	NDC: 30775-051-32	2 in 1 CASE	08/23/2018
5		6 in 1 BOX
5		917.62 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
6	NDC: 30775-051-50	4 in 1 CASE	08/23/2018
6		3686 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/23/2018

Labeler - Parker Laboratories, Inc. (002449593)

Establishment
Name	Address	ID/FEI	Business Operations
Parker Laboratories, Inc.		002449593	manufacture(30775-051)