ROCKSAUCE ICE- menthol cream

rocksauce ice by

Drug Labeling and Warnings

rocksauce ice by is a Otc medication manufactured, distributed, or labeled by NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Menthol     6%

Purpose

Topical Analgesic

Uses:

For temporary relief minor muscular discomfort

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Keep out of reach of children.

if accidentally ingested, getmedical help or contact a Poison Control Center immediately.

Directions:

For the temporary relief of minor muscular discomfort. See important warnings under "When using this product". Not for use on children 5 years or younger. Apply liberally to painful area and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68 to 77F (20 to 25 C)

When using this product

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Consult a doctor and discontinus use.

if conditions persist for more than 1 week or reocur.

Inactive ingredients:

Water, Isopropyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Calendula Officinalis Extract, Arctium Lappa (Burdock)Root Extract, Illex Paraguariensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, CamelliaSinensis (Green Tea) Leaf Extract, Melissa Officinalis (Lemon Balm) Leaf Extract, Camphor, Isopropyl Myristate, Carbomer,Triethanolamine, Silica, Tocopheryl (Vitamin E) Acetate

Principal Display Panel

INGREDIENTS AND APPEARANCE

ROCKSAUCE ICE 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73344-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	6 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73344-105-01	1 in 1 PACKAGE	09/29/2019
1		355 mL in 1 BOTTLE; 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	part348	09/29/2019

Labeler - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD		404080257	manufacture(73344-105)