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Crystal Connections, 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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For external use only

Do not use on open cuts

When using this product do not get into eyes

Do not ingest

Stop use and ask a doctor if:

Condition worsens

Sensitivity develops or increases

Symptoms last more than 7 days or clear up and occur again in a few days

PURPOSE

Skin protectant

DOSAGE & ADMINISTRATION

Apply to affected area

Rub vigorously

Rinse off salt only

Pat dry the waxy residue

Apply as needed

ACTIVE INGREDIENT

Oatmeal

INACTIVE INGREDIENT

Almond oil

Beeswax

Jojoba oil

Lanolin

Lavender

Sea salt

Vitamin E Oil

OTC - KEEP OUT OF REACH OF CHILDREN

If swallowed get medical help or contact a poison control center immediately

INDICATIONS & USAGE

Temporarily protects and helps relieve minor skin irritation and itching due to: poison ivy, insect bites, eczema

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60858-314
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.0287 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALMOND OIL (UNII: 66YXD4DKO9)
Yellow Wax (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
LANOLIN (UNII: 7EV65EAW6H)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60858-314-04	113.4 g in 1 BOTTLE
2	NDC:60858-314-01	28.35 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/06/2014

Labeler - Crystal Connections, LLC (016582119)

Name	Address	ID/FEI	Business Operations
Establishment
American Pharmaceuticals and Cosmetics		038023805	manufacture(60858-314)

Revised: 1/2014

Document Id: 443b29d5-edb3-4213-8109-9cf2b1729111

Set id: 76e086d8-0e96-4b6b-b9bc-c7b98a02e300

Version: 2

Effective Time: 20140103

Crystal Connections, LLC