CVS HEALTH FIRST AID OUTDOOR PREP-PACK- ammonia kit

CVS Health First Aid Outdoor Prep-Pack by

Drug Labeling and Warnings

CVS Health First Aid Outdoor Prep-Pack by is a Otc medication manufactured, distributed, or labeled by CVS, Tender Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Active Ingredient:

Ammonia 3.5%

Purpose

Counterirritant

Use

Temporarily protects and helps relieve minor skin irriatation and itching due to

• insect bites and stings
• poison ivy, oak or sumac
  

Warnings

Warning:   For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days
  

When using this product

Do not get into eyes

Directions

Adults and children under 2 years and older dab directly on bite or sting, rub gently and re-apply as needed

Children under 2 years ask a doctor

Inactive Ingredients

Alcohol Ethoxylate, Dimethicone, Mineral Oil and Purified Water

PRINCIPAL DISPLAY PANEL

After Bite

The Itch Eraser

Fast Relief from Insect Bites.

Net Contents: 0.037fl. oz.

Contains: One (1) Wipe

Contains Ammonia

Tender Corporation

Littleton, NH 03561

INGREDIENTS AND APPEARANCE

CVS HEALTH FIRST AID OUTDOOR PREP-PACK 
ammonia kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-407

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-407-00	1 in 1 KIT; Type 0: Not a Combination Product	12/01/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PACKAGE	3 mL

Part 1 of 1

AFTER BITE WIPE 
ammonia swab

Product Information
Item Code (Source)	NDC: 44224-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X)	AMMONIA	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)
C12-13 ALCOHOLS (UNII: T7ZJT3I9X2)
DIMETHICONE 1000 (UNII: MCU2324216)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44224-0001-2	0.7 mL in 1 PACKAGE; 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	04/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/01/2014

Labeler - CVS (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Tender Corporation		064437304	manufacture(69842-407)