LITTLES ALL NATURAL ARTHRITIC PAIN RELIEF- capsacin ointment

Littles All Natural Arthritic Pain Relief by

Drug Labeling and Warnings

Littles All Natural Arthritic Pain Relief by is a Otc medication manufactured, distributed, or labeled by Littles Skin Care, Inc., Littles Skin Care, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

capsaicin, menthol

INACTIVE INGREDIENT

Sunflower oil, Coconut oil, Camphor, beeswax, shea-butter, cocoa-butter, mixed tocopherol

ASK DOCTOR/PHARMACIST

If pregnant or nursing, consult a physician before use.

If 18 years or younger, consult a physician before use.

PURPOSE

temporarily helps relieve sore muscles and joint pain (arthritic) pain.

DOSAGE & ADMINISTRATION

10 g/100 g menthol; 1 g/1000 g capsasin

INSTRUCTIONS FOR USE

Massage the painful area until thoroughly absorbed. Wash hands thorougly after use. If burning sensation occurs, stop its use. Wash the area with soap and water or with vinegar and then with soap and water.

You may use a glove for applying.

STOP USE

If burning sensation occurs, stop its use. Wash the area with soap and water or with vinegar and then with soap and water.

STORAGE AND HANDLING

Store between 50 - 70F

KEEP OUT OF REACH OF CHILDREN

This product is only for people over 18 years of age. For 18 years or younger, please consult a physician before use.

WARNINGS

Do not use if 18 years or younger, Consult a physician before use. Do not contact with eyes. Do not ingest.

Wash hands thorougly after use. If burning sensation occurs, stop its use. Wash the area with soap and water or with vinegar and then with soap and water.

INDICATIONS & USAGE

Massage the painful area until thoroughly absorbed.. Apply twice a day.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LITTLES ALL NATURAL ARTHRITIC PAIN RELIEF 
capsacin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71976-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COD LIVER OIL (UNII: BBL281NWFG)	3 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71976-602-01	1 g in 1 JAR; Type 6: Drug/Biologic Combination	01/26/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/26/2018

Labeler - Littles Skin Care, Inc. (058087047)

Establishment
Name	Address	ID/FEI	Business Operations
Littles Skin Care, Inc		058087047	manufacture(71976-602)