4RLF TOPICAL ANALGESIC- menthol cream

4RLF Topical Analgesic by

Drug Labeling and Warnings

4RLF Topical Analgesic by is a Otc medication manufactured, distributed, or labeled by Rinati Skin, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Menthol 0.10%

PURPOSE

TOPICAL ANALGESIC

USES

For the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.

WARNINGS

For external use only. When using this product ■ Avoid contact with eyes. In case of eye contact, flush eyes with water. ■ If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

■ Keep out of reach of children.

 If swallowed, get medical help.

DIRECTIONS FOR USE

■ Adults and children 2 years of age or older:
Apply to the desired area and gently rub into the skin, not more than
3 to 4 times daily. ■ Children under the age of 2: Consult a physician.

INACTIVE INGREDIENTS

Propylene Glycol, Ocimum Tenuiflorum Callus Culture Lysate, Glycerin, Dimethyl Sulfone, Water, Withania Somnifera Root Extract, Piper Nigrum (Pepper) Fruit Extract, Gluconolactone, Sodium Benzoate, Citric Acid, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Oil, Hydroxyethylcellulose.

OTHER INFORMATION

■ Storage Instructions: Store in a cool, dark place (<100°F). Avoid storage directly in sunlight.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

4RLF TOPICAL ANALGESIC 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76849-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCIMUM TENUIFLORUM WHOLE (UNII: 7OS52KZ33J)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
WATER (UNII: 059QF0KO0R)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
PIPER NIGRUM WHOLE (UNII: 49L10LI8DN)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76849-201-11	1 in 1 CARTON	08/23/2021
1		10 in 1 BLISTER PACK
1		1 mL in 1 VIAL; 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	08/23/2021

Labeler - Rinati Skin, LLC (109530208)