AVAPTA- menthol cream
Neel Products LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AVAPTA Penetrating Muscle and Joint

Active Ingredient

Menthol 4%

Purpose

External Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to
Arthritis
Bursitis
Strains
Sprains
Aches and pain from overexertion
Muscle cramps
Bruises
Simple backache

Warnings

For External Use ONLY

When using this product

Use only as directed
Avoid Contact with eyes or mucous membranes
Do not apply to wounds or to damaged or irritated skin
Do not bandage or use with a heating pad
Do not use in combination with other external analgesic products

Stop use and ask a doctor if

Condition worsens
Symptoms persist for more than 7 days
Symptoms clear up and occur again in a few days
Redness or excessive skin irritation occurs

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control center right away

Directions

Adults and children 12 years and over, apply to affected area 2 to 4 times daily
Apply generously, partially rub in, penetrates and dries very quickly leaving no residue.
Children under 12 years, ask doctor before using
Do not use on children under 2 years of age

Inactive ingredients

Aloe Vera Whole Leaf Extract, Clove Oil, Mentha Arvensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Morinda Citrifolia Fruit Extract, Purified Water, Saline, Titanium dioxide, Vinegar, Xanthan Gum, Fragrance

Questions? 1-859-509-0436

Principal Display

AVAPTA

Penetrating Muscle and Joint

Pain Relief Cream

External Analgesic

NDC#76332-001-03

For:

Arthritis
Muscle Cramps
Back Aches
Sprains
Strains
Tendonitis
Bursitis
Bruises
Aches and Pain from Overexertion

ALL NATURAL INGREDIENTS

No Alcohol
No Parabens
No Benzocaine
No Petroleum

Manufactured for

Neel Products LLC

1900 Woodlake Rd

Stamping Ground, KY 40379

info@avapta.com

76332-001

AVAPTA
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76332-001
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CLOVE OIL (UNII: 578389D6D0)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
WATER (UNII: 059QF0KO0R)
NONI FRUIT (UNII: 7829X3G2X5)
TEA TREE OIL (UNII: VIF565UC2G)
ACETIC ACID (UNII: Q40Q9N063P)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76332-001-04	452 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2011	10/13/2015
2	NDC:76332-001-02	226 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2011	10/13/2015
3	NDC:76332-001-03	113 g in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2011	10/13/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	09/01/2011	10/13/2015

Labeler - Neel Products LLC (968478102)

Revised: 10/2015

Document Id: 2203a95e-d61d-5e2c-e054-00144ff8d46c

Set id: 36afa636-0778-48b4-ab63-041e711afb5e

Version: 4

Effective Time: 20151013

Neel Products LLC