RITE AID ROLL-ON- menthol gel

Rite Aid Roll-On by

Drug Labeling and Warnings

Rite Aid Roll-On by is a Otc medication manufactured, distributed, or labeled by SOTAC PHARMACEUTICALS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Menthol USP 4%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with:  - arthritis, - backache,  - strains, - sprains

Warnings:

For external use only

Flammable:

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

Sensitive skin

When using this product:

• Avoid contact with eyes or mucous membranes
• Do not apply to wounds or damaged skin.
• Do not use with other ointments, creams, sprays, or liniments.
• Do not apply to irritated skin or if excessive skin irritation develops.
• Do not bandage
• Wash hands after use with cool water
• Do not use with heating pad or device.
  

Stop use and ask a doctor if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breast-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 2 years of age: Consult physician

Inactive Ingredients:

Aloe Vera gel, Camphor, Carbomer, FD&C blue 1, FD&C yellow 5 Glycerol, Isopropyl Alcohol, Ispropyl Myristate, Purified water, Silica, triethanolamine, Tocopheryl (Vitamin E) Acetate, 

Other Information:

Store in a cool dry place with lid closed tightly

Questions or Comments

1-855-314-1850

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RITE AID ROLL-ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72351-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
FRANKINCENSE (UNII: R9XLF1R1WM)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72351-008-00	96 in 1 PACKAGE; Type 0: Not a Combination Product	08/09/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/09/2018

Labeler - SOTAC PHARMACEUTICALS PRIVATE LIMITED (876894019)