AVAPTA- allantoin, hexylresorcinol, menthol and camphor (natural) spray
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 Burns - Cuts - Poison Ivy

Drug Facts

Active Ingredients

Allantoin 0.5%
Hexylresorcinol 0.1%
Menthol 0.4%
White Camphor 0.9%

Purpose

Skin Protectant
External Antiseptic
External Analgesic
External Analgesic

Uses

For the temporary relief of pain and itching due to

Minor Burns
Sunburn
Minor Cuts
Scrapes
Insect Bites
Minor Skin Irritations
Rashes due to Poison Ivy, Poison Oak and Poison Sumac
First Aid to help prevent infection in the above

Warnings

For external use ONLY

Ask a doctor before use if you have

Deep or Puncture Wounds
Animal Bites
Serious Burns

When using this product

Do not apply over large areas of the body
Do not get in eyes or around anal or vaginal areas

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

Shake before each use
Keep spray tip clean
Adults and children 2 years of age and older, spray on affected area 2 to 3 times daily.
May be covered with a sterile bandage, let dry first
Children under 12 years of age should be supervised when using this product
Children under 2 years of age, ask a doctor
To apply to face, spray in palm of hand and gently apply

Inactive ingredients

Aloe Vera Whole Leaf Extract, Clove Oil, Lavender Oil, Mentha Arvensis Leaf Extract, Melaleuca Alternifolia (tea tree) Leaf Oil, Morinda Citrifolia Fruit Extract, Vinegar, Fragrance

Questions?

1-859-509-0436

Principal Display Panel

New

AVAPTA

Burns - Cuts - Poison Ivy

Pain Relieving - First Aid Spray

External Analgesic/External Antiseptic/Skin Protectant

Minor Burns
Sunburn
Minor Cuts
Insect Bites
Minor Skin Irritations
Poison Ivy/Poison Oak/Poison Sumac

99.4% ALL NATURAL PLANT BASED INGREDIENTS

No Alcohol
No Parabens
No Benzocaine
No Petroleum

Manufactured for

Neel Products LLC

1900 Woodlake Rd

Stamping Ground, KY 40379

info@avapta.com

76332-002

AVAPTA
allantoin, hexylresorcinol, menthol, white camphor spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76332-002
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg in 1 mL
HEXYLRESORCINOL (UNII: R9QTB5E82N) (HEXYLRESORCINOL - UNII:R9QTB5E82N)	HEXYLRESORCINOL	1 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 mg in 1 mL
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CLOVE OIL (UNII: 578389D6D0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
NONI FRUIT (UNII: 7829X3G2X5)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
ACETIC ACID (UNII: Q40Q9N063P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76332-002-01	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/06/2012	10/13/2015
2	NDC:76332-002-02	89 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/06/2012	10/13/2015
3	NDC:76332-002-03	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/06/2012	10/13/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/06/2012	10/13/2015

Labeler - Neel Products LLC (968478102)

Revised: 10/2015

Document Id: 2203ab39-8154-13f0-e054-00144ff88e88

Set id: 1f16ad52-9af9-44c2-b650-9bb10bde321c

Version: 2

Effective Time: 20151013

Neel Products LLC