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NDC 63264-0102-08 SWIMMERS ITCH GUARD 20 g/100mL Details

SWIMMERS ITCH GUARD 20 g/100mL

SWIMMERS ITCH GUARD is a TOPICAL OIL in the HUMAN OTC DRUG category. It is labeled and distributed by RESOLUTIONS LLC. The primary component is EUCALYPTUS OIL.

Product Information

NDC	63264-0102
Product ID	63264-102_d84ed2d3-219c-7907-e053-2995a90a3764
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SWIMMERS ITCH GUARD
Proprietary Name Suffix	n/a
Non-Proprietary Name	EUCALYPTUS
Product Type	HUMAN OTC DRUG
Dosage Form	OIL
Route	TOPICAL
Active Ingredient Strength	20
Active Ingredient Units	g/100mL
Substance Name	EUCALYPTUS OIL
Labeler Name	RESOLUTIONS LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 63264-0102-08 (63264010208)

Pricing Information	N/A
NDC Package Code	63264-102-08
Billing NDC	63264010208
Package	237 mL in 1 JAR (63264-102-08)
Marketing Start Date	2022-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d84ed5cb-9e0d-977d-e053-2995a90aadc1 Details

ACTIVE INGREDIENT

EUCALYPTUS OIL 20%

PURPOSE

SKIN PROTECTANT

USES

PREVENT SWIMMER'S ITCH
SAFE FOR CHILDREN
LONG LASTING PROTECTION

WARNINGS

TOPICAL CREAM - FOR EXTERNAL USE ONLY - KEEP OUT OF EYES. FLUSH THOROUGHLY AND GENTLY WITH WARM WATER FOR 10-15 MINUTES. STOP USE AND CONSULT PHYSICIAN IF RASH OR IRRITATION DEVELOPS. CONSULT PHYSICIAN BEFORE USING IF PREGNANT OR NURSING.

SPL UNCLASSIFIED SECTION

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

DIRECTIONS (FOR CHILDREN 2 YEARS AND OLDER AND ADULTS):

Apply sunscreen first, especially spray-on sunscreens which contain alcohol (alcohol removes our product). Before entering the water, apply Swimmer’s Itch Guard to all uncovered skin that will be under water continuously for 5 minutes or longer. Apply liberally and evenly. When coming out of the water, light toweling off is best because it minimizes removal of Swimmer’s Itch Guard. Reapply after 60 minutes of water activity, taking a shower or hot-tub, or repeated hard toweling offs. Wash swimsuits separately in warm water.

OTHER INGREDIENTS:

Fractionated Coconut Oil, Olive Oil, Avocado Oil, High Oleic Safflower Oil, Cinnamon Oil, d-alpha Tocopherol (Vitamin E).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SWIMMERS ITCH GUARD

eucalyptus oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63264-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	20 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OLIVE OIL (UNII: 6UYK2W1W1E)
SAFFLOWER OIL (UNII: 65UEH262IS)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
AVOCADO OIL (UNII: 6VNO72PFC1)
CINNAMON OIL (UNII: E5GY4I6YCZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63264-102-08	237 mL in 1 JAR; Type 0: Not a Combination Product	02/18/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/18/2022

Labeler - RESOLUTIONS LLC (047149101)

Revised: 2/2022

Document Id: d84ed2d3-219c-7907-e053-2995a90a3764

Set id: d84ed5cb-9e0d-977d-e053-2995a90aadc1

Version: 1

Effective Time: 20220217