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NDC 69233-0644-03 Reliaderm .035; 10; 25 g/100g; g/100g; g/100g Details

Reliaderm .035; 10; 25 g/100g; g/100g; g/100g

Reliaderm is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Icon Health Services, Llc. The primary component is CAPSAICIN; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	69233-0644
Product ID	69233-644_48a82be6-a24e-1f78-e054-00144ff8d46c
Associated GPIs	90809903303750
GCN Sequence Number	074370
GCN Sequence Number Description	capsaicin/me-salicylate/menth CREAM RLON 0.035%-25% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	38996
HICL Sequence Number	002572
HICL Sequence Number Description	CAPSAICIN/METHYL SALICYLATE/MENTHOL
Brand/Generic	Brand
Proprietary Name	Reliaderm
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHYL SALICYLATE, MENTHOL, CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.035; 10; 25
Active Ingredient Units	g/100g; g/100g; g/100g
Substance Name	CAPSAICIN; MENTHOL; METHYL SALICYLATE
Labeler Name	Icon Health Services, Llc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69233-0644-03 (69233064403)

Pricing Information	N/A
NDC Package Code	69233-644-03
Billing NDC	69233064403
Package	85 g in 1 BOTTLE, WITH APPLICATOR (69233-644-03)
Marketing Start Date	2014-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 25feb00b-5ca6-405a-9432-de3fbb334f59 Details

Drug Facts

Active Ingredients:

Methyl Salicylate 25.00%

Menthol 10.00%

Capsaicin 0.035%

Topical Analgesic

Uses:

For temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Warnings:

For external use only.
Avoid contact with eyes and mucous membranes.
Do not bandage tightly or cover treated areas.

Do not use

with heating pad.
Do not apply to open wounds or damaged skin.
A mild burning sensation may occur. If severe burning sensation occurs, discontinue use immediately.
If symptoms persist for more than seven days, discontinue use and consult a physician.

Keep out of reach of children.

If swallowed, consult physician.

If pregnant or breast feeding,

contact physician prior to use.

Directions: For Adults:

Apply directly to effected area. Repeat as necessary, but do not use more than 3-4 times daily. Children under two, consult a physician.

Other Ingredients:

Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Phenoxyethanol, Sodium Lauryl Sulfate, Stearic Acid, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

RELIADERM

methyl salicylate, menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69233-644
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	25 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.035 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETYL ALCOHOL (UNII: 936JST6JCN)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69233-644-03	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/24/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/25/2014

Labeler - Icon Health Services, Llc (079435759)

Revised: 2/2017

Document Id: 48a82be6-a24e-1f78-e054-00144ff8d46c

Set id: 25feb00b-5ca6-405a-9432-de3fbb334f59

Version: 6

Effective Time: 20170216